Clinical Research Directory

Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes

The goal of this clinical trial is to evaluate how different time ratios of aerobic and resistance training affect blood glucose levels and physical health in adults aged 50 years and older with prediabetes. Researchers will compare three combined exercise programs with aerobic-to-resistance training time ratios of 3:1, 1:1, and 1:3 with a health education control group. Participants in the exercise groups will take part in supervised training three times per week for 12 weeks. Each session will include approximately 60 minutes of aerobic and resistance exercise, with the amount of time spent on each type of exercise differing according to the assigned group. Participants will complete health assessments before and after the 12-week intervention. The main outcome of interest is glycated hemoglobin (HbA1c), which reflects average blood glucose levels over the previous 2 to 3 months. Participants in the control group will receive standardized health education and will not take part in the study-provided structured exercise program during the 12-week intervention period.

TREAT to Improve Cardiometabolic Health

Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Time restricted eating (TRE), a novel type of intermittent fasting, facilitates adherence to the intervention and results in weight loss and improvement of metabolism. The investigators propose to examine the efficacy of self-monitoring and TRE (10-h/d) vs. self-monitoring and habitual prolonged eating duration (HABIT) (13 hours/d) on weight loss and body composition, metabolic function and circadian biology, in metabolically unhealthy adults aged 50 to 75 y old, with overweight or obesity. The investigators hypothesize that TRE, compared to habitual long duration of eating, will decrease cardiovascular risk burden.

Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality

Primary objective: To evaluate the effectiveness of the ARISE strategy on the proportion of individuals with confirmed T2DM diagnosis, per protocol criteria based on the PCDT-DM2 (Clinical Protocol and Therapeutic Guidelines for T2DM), among adults eligible for screening registered at UBS (Primary Health Care Units) in Afogados da Ingazeira, during the 12 months post-implementation, compared to a reference value estimated from a historical 12-month period in the same municipality. Methodology: Pragmatic, quasi-experimental, single-arm effectiveness and implementation study with a historical comparator. In each period, the analytic population will be defined by eligibility on the respective index date. In the historical period, data will estimate the reference proportion of the primary outcome and historical values of applicable secondary outcomes. In the post-intervention period, individuals eligible on the index date will be followed for 12 months via care records. Individuals who become eligible after the post-intervention index date may receive care actions under the strategy and be included in operational, implementation, and exploratory analyses, but not in outcome denominators fixed at the index date. The study will take place in Afogados da Ingazeira, Pernambuco, covering all 15 UBS with an affiliated Family Health Team. Research-specific technological components will incur no additional cost to the municipality. ARISE comprises two components: 1. Digital analytics layer, built on the existing epHealth infrastructure. It uses structured data from e-SUS PEC to apply predefined T2DM screening eligibility rules. Identified individuals appear in operational lists and may generate alerts for UBS managers and community health workers, supporting visits, scheduling, test requests, follow-up, and patient return. It may also flag: delays over 60 days between test request and completion, availability of lab results, and need for active case-finding. No test, diagnosis, prescription, referral, or treatment is automated; clinical decisions remain with APS professionals and managers. 2. Professional training. UBS managers, community health workers, physicians, nurses, and nursing technicians will be trained on the PCDT-DM2 and ARISE workflows, before the digital layer's activation. Professionals are research participants only for evaluating educational impact, acceptability, and usability, provided they attend the relevant training and sign the Informed Consent Form (ICF). Training participation is independent of research participation; declining data use carries no functional or institutional penalty. A census-based approach will define population size. The primary analysis includes all individuals eligible on the post-intervention index date; final numbers depend on municipal database findings. Power calculations covered 8,000-30,000 eligible individuals and historical T2DM diagnosis proportions of 0.80%-0.90%. A population of \~14,000-15,000 eligible individuals yields \~80% power to detect a \~25% relative increase, for historical proportions of 0.85%-0.90%. For professional-related components, a census approach covers all eligible categories per the updated roster of active professionals directly involved. Statistical analysis: The post-intervention proportion of confirmed T2DM diagnosis will be compared to the historical reference using a two-tailed one-proportion test (5% significance level). Point estimates, 95% CIs, absolute differences, and proportion ratios (where applicable) will be reported. Adjusted analyses may use logistic regression. Change in professionals' knowledge will be analyzed via paired intra-individual pre/post-training score differences. RE-AIM indicators will be mainly descriptive. Acceptability, training reaction, and workflow perception blocks will be scored separately (1-5). Usability will be assessed via the System Usability Scale (0-100) among professionals who directly used the digital component. The study was approved by the Research Ethics Committee (REC), CAAE n. 00260026.5.0000.5330, approval opinion n. 8.705.723. Primary outcome: Confirmed T2DM diagnosis during the observation period, treated as a binary individual indicator.

The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer

This trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes (elevated blood sugar level that is not high enough to be considered diabetes). Nicotinamide riboside is a dietary supplement which is similar to vitamin B3. Information collected in this study may help the future development of regimens to improve metabolic outcomes such as muscle health and insulin resistance (when the body is not normally responding to insulin) in childhood cancer survivors.

Efficacy of the pA1c®HI Postbiotic in Metabolic Regulation in Healthy Individuals With Hyperglycemia

This study will evaluate the effects of pA1c®HI, a heat-inactivated postbiotic derived from the bacterium Pediococcus acidilactici, on blood glucose regulation and other aspects of metabolic health in adults with elevated blood glucose levels who do not have diagnosed diabetes. The study will include approximately 100 adults aged 18 to 80 years with glycated hemoglobin (HbA1c) levels of 5.7% to less than 6.5%, a range consistent with prediabetes. A postbiotic is a preparation of inactivated microorganisms and/or their components that may provide health benefits. pA1c®HI does not contain live bacteria. This is an open-label, single-group study. All participants will take one capsule of pA1c®HI daily for 12 weeks. There is no placebo or separate control group. Researchers will compare measurements taken before and after the intervention to assess changes over time. Participants will continue their usual medical care and previously established lifestyle recommendations. The study will include assessments at the beginning and end of the intervention. These will include blood tests, measurements of body weight and other physical characteristics, questionnaires, and continuous glucose monitoring for 14 days at each assessment period. Participants will also provide stool samples for analysis of gut microbiota composition. Blood tests will assess glycated hemoglobin, fasting glucose, insulin-related markers, blood lipids, liver function, and other parameters. Researchers will also measure glucagon-like peptide-1 (GLP-1), a hormone involved in blood glucose regulation, including its response to a mixed meal. The main objective is to evaluate changes in HbA1c after 12 weeks of daily pA1c®HI supplementation. Other objectives include assessing changes in glucose levels and variability, insulin resistance markers, blood lipids, GLP-1 responses, gut microbiota composition, and body measurements. The study will also assess adherence to supplementation and monitor safety and tolerability. The findings will help researchers understand the potential effects of pA1c®HI on metabolic health in adults with elevated blood glucose levels. Because the study does not include a placebo or control group, changes observed during the study cannot be attributed to the postbiotic with the same certainty as in a controlled trial.

Smartwatch-based Intervention for Cardiovascular Health (SWITCH)

This study aims to employ a cluster randomized controlled trial to evaluate the effectiveness of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model among metabolically at-risk people with overweight/obesity, thereby providing theoretical foundations and practical guidance for the prevention and management of this population.

LIfestyle MEtabotype Study B (LIME-B)

Glycemic responses vary significantly among individuals, even when consuming identical foods or meals, but the factors predicting individual glucose responses to food intake remain poorly investigated. The aim of the LIfestyle MEtabotype (LIME) study is to identify lifestyle-related and mechanistic factors which predict individual postprandial glucose fluctuations in individuals with different glycemic status (prediabetes, type 2 diabetes \[T2D\] and absence of prediabetes or T2D), using comprehensive lifestyle characterization and metabolic, molecular and neurocognitive phenotyping. As part of this phenotyping, the LIME study also investigates the role of ketone bodies. Individuals with insulin resistance, prediabetes or T2D often show impaired cerebral glucose utilization. Ketone bodies, such as β-hydroxybutyrate (βHB) may serve as an alternative energy source for the brain. However, how exogenous βHB affects neurocognitive processes and decision-making in individuals with different glycemic status remains poorly understood. This record describes module B of the LIME study. Module B investigates the effects of a single dose of exogenous βHB, compared with a carbohydrate-based placebo drink, on brain structure and function, decision-making behavior and physiological and metabolic responses. Module A comprises a comprehensive lifestyle and metabolic characterization of the same participants and is registered separately as an observational study (NCT07868601). Data from both modules will be integrated in joint analyses.

Trial of CGM Technology in Persons Living With Prediabetes

Continuous glucose monitor (CGM) technology has become increasingly prevalent in the population and has the ability to transform care of patients living with prediabetes. While the technology was initially utilized primarily by patients living with type 1 diabetes using insulin pump therapy, it has become more widely used as part of care in patients living with type 1 or 2 diabetes on any kind of insulin therapy.

Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans

This nested pilot Randomized Clinical Trial will determine whether the Diabetes Prevention Program (DPP) enhanced with evidence-based sleep health and time restricted eating interventions ("DPP++") is more effective than the DPP alone for improving metabolic and cardiovascular metrics in 40 overweight/obese adults with prediabetes.

Continuous Glucose Monitoring and Dietary Self-Management in Adults in Namwon

This study will test whether adding a continuous glucose monitoring (CGM) device, which shows personal glucose patterns, improves dietary self-management over the first 6 weeks. Both groups receive the same digital health program, standardized education, and support for setting behavioral goals. It will include 860 residents of Namwon, Republic of Korea, aged 40 years or older who have elevated fasting glucose or documented type 2 diabetes diagnosis or treatment. After screening, participants will be assigned by chance to one of two groups of 430. Assignment is preferably on the first screening visit but may occur later. The actual assignment date is Day 0. The device group will use one CGM sensor for approximately 10 days after assignment. The wait-list control group will receive the same education and behavioral goal-setting support during the first 6 weeks, without a CGM device. Researchers will compare dietary self-management scores at week 6, before the control group receives a sensor. After the week 6 assessment and data lock, the control group will also be offered a sensor so that all eligible randomized participants have an opportunity to use the device. This later offer is not the main intervention comparison. Week 12 assessments provide exploratory follow-up after both groups have been offered a device. Researchers will also assess application use, body weight, waist circumference, blood pressure, and safety. The research team will not change medicines based on sensor readings, and usual medical care will continue.

Efficacy of Diacylglycerol Oil on Metabolic Risk Factors in Prediabetes

This study will implement a four-week dietary intervention among middle-aged and older adults with pre-diabetes. Participants assigned to the intervention arm will replace their usual cooking oil with diacylglycerol (DAG) oil, while those in the control arm will consume colza oil. All other lifestyle behaviors will be maintained without modification. The trial will determine the impact of DAG oil consumption on glycemic regulation, lipid metabolism, and body composition in this high-risk population.

New T-UP: Engaging Vulnerable Students in Diabetes Prevention

The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity. The specific aims are: Aim 1 - Evaluate the efficacy of an AYA-tailored version of the UC DPP for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months). Aim 2 - Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP. The investigators will recruit 80 UCLA undergraduate students. Participants will be asked to complete a brief screening online form to assess eligibility and to collect contact information. The PI and/or Research Assistants (RAs) will reach out to eligible participants to obtain informed consent and enroll them in the pilot trial. The investigators will randomize participants to the tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the tailored DPP in the following academic year. The tailored DPP intervention will be online and asynchronously. Participants will be asked to complete the intervention lessons on their own time. Each lesson typically takes on average 15 minutes to complete. Control group will receive each intervention materials via e-mail for participants to review on their own time and will receive acceptability surveys. The interventions for the control group will be remote. A research assistant will meet with control participants via Zoom to explain the intervention materials. Control group will receive access to a study habits intervention, alcohol use intervention, and financial literacy intervention. At the end of each quarter (Fall, Winter, and Spring), both control and intervention participants will receive an email with a unique link to a brief REDCap survey to ascertain acceptability of sessions/lessons. Furthermore, participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey.

Diabetes Prevention Through Genetics, Familial History and Behavior Change

The goal of this clinical trial is to learn if adding a family engagement component to the standard Diabetes Prevention Program (DPP) improves outcomes for adults with prediabetes. It will also learn about the effects of this approach on family members' health. The main questions it aims to answer are: * Does adding family health history collection and family participation to the DPP improve session attendance compared to standard DPP? * Does this family-centered approach lead to greater weight loss and HbA1c (blood sugar) reduction compared to standard DPP? * Do health improvements extend to participants' family members, and what factors explain differences in family-level outcomes? Researchers will compare an adapted DPP with a family component to the standard DPP (individual-focused) to see if involving family members improves diabetes prevention outcomes. Participants will: * Be assigned to one of two groups: adapted DPP with family sessions, or standard DPP * If assigned to the adapted DPP, complete a family health history using the Center for Disease Control and Prevention's (CDC) My Family Health Portrait tool and attend 6 additional sessions with family members focused on personalized risk communication * Attend regular checkups to measure weight and HbA1c at 6 and 12 months * Have session attendance tracked throughout the program * Family members of participants may also be asked to complete health assessments to measure any changes in their own health behaviors

Piloting FUERTE: Federally qUalified Health Centers Engaging Hispanic Men at Risk of diabeTEs

The goal of this study is to learn whether FUERTE (Federally qUalified Health Centers Engaging Hispanic Men at Risk of diabeTEs) can facilitate referrals of Hispanic men with prediabetes to the Diabetes Prevention Program (DPP) and support their continued engagement in the program. The main questions it aims to answer are: Does implementation of the FUERTE strategy increase the number of DPP-eligible Hispanic men who are referred to and enrolled in the DPP? Does implementation of the FUERTE strategy improve engagement in the DPP and result in greater improvements in weight and hemoglobin A1C among Hispanic men participating in the program? FUERTE consists of three components: 1. Information sessions for healthcare providers to increase awareness of the DPP. 2. Text messages sent to DPP-eligible Hispanic men reminding them of appointments and encouraging discussions about prediabetes with healthcare providers. 3. Interactive WhatsApp group messages for Hispanic men referred to the DPP, providing tailored content and discussion prompts related to each core DPP session. Participants will: * Complete a survey before enrolling in the DPP. * Complete a survey after completing the DPP. * Those participating post-implementation of FUERTE will (1) receive text-messages, reminding them of their appointments and encouraging discussions about prediabetes with providers, and (2) receive interactive group-messages, delivered through WhatsApp, to supplement the standard of care DPP with tailored topics and prompts.

Glycemic Impact of NNS Via the Gut Microbiome

This pilot study will evaluate the feasibility and acceptability of a 30-day sucralose intervention among adults with prediabetes. Participants will consume six commercial sucralose (Splenda®) packets daily for 30 days while wearing a blinded continuous glucose monitor (CGM). Oral glucose tolerance tests (OGTTs) with blood draws will be performed at baseline and after 30 days to assess glucose incremental area under the curve (iAUC). Stool samples will also be collected to assess the feasibility of microbiome sample collection for future studies. The study will generate preliminary data to inform the design of a larger randomized clinical trial examining the effects of non-nutritive sweeteners on glucose homeostasis and the gut microbiome.

LIfestyle MEtabotype Study A

Glycemic responses vary significantly among individuals, even when consuming identical foods or meals, but the factors predicting individual glucose response to food intake remain poorly investigated. The aim of the LIfestyle MEtabotype study (LIME) observational study is to identify lifestyle-related and mechanistic factors which predict individual postprandial glucose fluctuations in individuals with different glycemic status (prediabetes, type 2 diabetes \[T2D\], and absence of prediabetes or T2D). To address this aim, the study will conduct a comprehensive lifestyle characterization and metabolic, molecular and neurocognitive phenotyping during study center visits and a dietary, glucose, sleep and activity monitoring during the observational phase.

Pharmacist-Led Continuous Glucose Monitoring for Prediabetes

The goal of this observational study is to determine if a pharmacist-led program involving continuous glucose monitoring (CGM) improves glucose control and health behavior in people with prediabetes. The main questions it aims to answer are: 1. Determine impact of pharmacist-led CGM on glycemic control in people with prediabetes. Researchers will compare change in hemoglobin A1c at 12 weeks with pharmacist-led CGM versus a historical cohort of subjects with prediabetes receiving no CGM. The investigators will also assess change in CGM-derived glycemic metrics from baseline to end of the CGM wear period in the intervention group. 2. Evaluate impact of pharmacist-led CGM on health behavior change in people with prediabetes in the intervention group. Participants will be asked to complete the Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF-36) at baseline, at the end of week 4, and at the end of the study so that researchers can measure the effects in the intervention group on health behavior change.

How a Mediterranean Diet With Potatoes Impacts Heart and Metabolic Health in Adults With Pre-Diabetes

The goal of this clinical trial is to is to determine the effects of baked potato with the skin (BP) + nutrition education focused on adherence for a Mediterranean Dietary Pattern (MEDNE) on glycemic control, cardiometabolic health, and dietary quality in individuals with pre-diabetes from different demographic backgrounds. The main questions it aims to answer are: * Does BP+MEDNE contribute to improvements in indices of glycemic control, vascular function, blood lipids, inflammation/oxidative stress, and body composition? * Does BP+MEDNE contribute to improvements to overall dietary intake and quality? Researchers will compare BP+MEDNE to MEDNE alone to see if BP+MEDNE can improve glycemic control, cardiometabolic health, and dietary quality in individuals with pre-diabetes from different demographic backgrounds. Participants will: * Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the study site for a Pre-Baseline and Pre-12-Week Study Visit (one week prior to Baseline and 12-Week Study Visits) for placement of placement of a continuous glucose monitor and wearable devices to be removed at Baseline and 12-Week Study Visits. * Be asked to come to the study site for Baseline, 6- and 12-Week Study Visits for assessments of glycemic control and cardiometabolic health. * Be asked to complete 3-Day Food Records throughout the 12 week study period for assessment of dietary quality (5 total) * Receive pre-recorded MEDNE ( which can be accessed via computer device/ipad/smartphone) after Baseline and 6-Week Study Visits. * If randomized to the BP+MEDNE group, participants will receive pre-prepared baked potatoes with the skin for the 12-week study period (every 3 weeks) at Baseline and 6-Week Study Visits and asked to come to the study site for picking up the pre-prepared baked potatoes at weeks 3 and 9 of the study period.

Mediterranean Diet and Blood Sugar Study

The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato/day has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease compared to a healthy Mediterranean diet without potatoes in adults with prediabetes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.

Multimodal Risk Factor Graph Mapping, Metabolic Subtyping, and Digital Intelligent Chronic Disease Management for Prediabetes: An Integrated Cohort and Case-Control Clinical Study

This observational study aims to understand the metabolic characteristics and long-term changes in adults with prediabetes and to identify risk and protective factors associated with progression to diabetes or return to normal glucose regulation. The study will include adults aged 20 to 69 years with prediabetes. The main questions this study aims to answer are: Which clinical characteristics, lifestyle factors, social and environmental factors, and genetic factors are associated with progression or improvement of prediabetes? How do blood glucose levels, pancreatic islet function, and other metabolic indicators change over time in people with prediabetes? Participants will complete questionnaires about their health status and lifestyle at baseline and during follow-up. According to the study schedule, they will also undergo blood glucose and other metabolic assessments, including an oral glucose tolerance test (OGTT). Some participants will undergo additional assessments, such as body composition analysis, liver elasticity measurement, and arterial stiffness testing. Blood, urine, and other biological samples may also be collected for further research. Participants will be followed over time to assess changes in glucose metabolism and lifestyle. Researchers will evaluate factors associated with return to normal glucose regulation, persistent prediabetes, or progression to diabetes. The findings may help improve early identification and personalized management of people at high risk of developing diabetes.

Training Induced Muscle-Adipose EV Communication

This study examines how muscle cells communicate with fat cells through tiny packages called extracellular vesicles (EV) during exercise. These vesicles carry important molecules that may affect how the body processes sugar and fat. The research team observed significant variability in the adipose response to exercise, and used this variability to gain further insight into the mechanism through which mature microRNA-1 (miR-1) changes in adipose tissue. The investigators selected six subjects with the highest increase in miR-1 abundance in adipose tissue after exercise and compared them with the six subjects that had the most dramatic decrease in miR-1 abundance after exercise. The research team observed that participants intrinsically vary in their ability to endocytose EV into adipose tissue. It is unclear whether this variance in receptivity is a cause or consequence of the significant difference in EV-delivery of miR-1 to adipose tissue.

WatchWell: Simple and Practical Strategies to Reduce the Negative Health Impact of Sedentary Screen Time

The purpose of this study is to determine the feasibility, acceptability, efficacy, and participant adherence in using home-based technologies and wearable devices and simple, practical strategies to reduce the negative impact that evening screen time may have on your health.

Precision Nutrition for Obesity and Prediabetes Prevention in Under-supported Communities

This randomized controlled trial will evaluate the effectiveness of a culturally sensitive precision nutrition intervention for improving obesity- and diabetes-related outcomes among African American and Hispanic/Latino adults who are overweight, obese, or have prediabetes. Participants will be randomized to either a precision nutrition intervention group or a control group receiving standard nutrition counseling and educational materials. The intervention incorporates individualized dietary recommendations based on participant characteristics, including dietary habits, physical activity, socioeconomic factors, psychosocial factors, phenotype, and genotype. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks and will include body weight, diet quality, fasting blood glucose, hemoglobin A1C, body composition, physical activity, blood pressure, and metabolic biomarkers. Feasibility, acceptability, and sustainability of the intervention will also be evaluated.

A Retrospective Real-World Cohort Study

The primary objectives are to determine the prevalence and overlap of major cardiometabolic diseases, identify multimorbidity clusters, and characterize demographic, clinical, laboratory, and treatment patterns across the cohort and relevant subgroups. This study is based on anonymized electronic health record (EHR) data and spanning January 2022 to December 2025. EHR will be extracted from participants of Acibadem hospital network in Turkey. Participants received routine clinical care according to physician discretion. Index date will be defined by the first diagnosis of cardiometabolic conditions. Follow-up period will include at least one year of to allow description of long-term outcomes. It will extend until the end of study, last recorded encounter, or death.