Clinical Research Directory

Effects of a Multispecies Probiotic on Metabolic, Liver, and Gut Health

The goal of this clinical trial is to learn if multistrain probiotic works to improve severe metabolic markers and gastrointestinal symptoms in obese MASLD patients. The main questions it aims to answer are Does this multistrain probiotic improve the composition of gut microbiota? Does it improve gastrointestinal symptoms and metablic profiles? Does it help in improving the grade of liver steatosis, and lose weight? Researchers will compare a multistrain probiotic group to a control group. Participants will: The probiotic group will take multistrain probiotics daily for 6 months in addition to a dietary plan and physical activity recommendations. The control group will only follow a dietary plan and physical activity recommendations Visit the clinic every 3 months for checkups and be called every month for regular follow-ups

Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.

The goal of this clinical trial is to evaluate the performance of a self-monitoring system (Solsius SelfCare) to detect pre-ulcerative clinical abnormalities in adults living with type 1 or 2 diabetes at high podiatric risk (grade 3 according to French HAS guidelines) and a history of healed diabetic foot wound. The main question it aims to answer is: \- Can the Solsius SelfCare system detect pre-ulcerative foot abnormalities with a sensitivity of at least 80%, defined as the proportion of temperature threshold exceedances (≥ 2.2°C difference between symmetric plantar sites over 2 consecutive days) confirmed by a clinical abnormality identified by a podiatrist? There is no comparison group. All participants will use the same device throughout the study. Participants will: * Wear the Solsius SelfCare connected insoles daily (except during sleep) for 12 months * Receive a push notification on their smartphone if a temperature difference ≥ 2.2°C is detected between symmetric sites on both feet over 2 consecutive days * Attend scheduled podiatric follow-up visits every 3 months (at M3, M6, M9, and M12) * Attend an additional unscheduled podiatric visit within 24 hours after each temperature alert, to verify the presence or absence of a pre-ulcerative clinical abnormality * Complete a self-questionnaire after each temperature alert and a usability questionnaire (System Usability Scale) at the end of the study

Dietitian-Nutritionist vs. Day Hospital in the Metabolic Control of Patients With Type 2 Diabetes

The present study aims to compare the effects on glycated hemoglobin (HbA1c) at 3 months of two care models in patients with type 2 diabetes referred due to poor glycemic control: a day hospital endocrinology care model versus a care model centered on follow-up by a dietitian-nutritionist.

RIGHTEST iFree 2 CGM System for Glycemic Control in Adults With Diabetes Mellitus

The goal of this clinical trial is to find out whether using a real-time continuous glucose monitoring (CGM) system can improve daily blood sugar control compared with usual self-monitoring of blood glucose (SMBG; finger-stick testing) in people with diabetes who are treated with insulin. This study will include adults with type 1 or type 2 diabetes who have less-than-ideal blood sugar control while using insulin. The main questions it aims to answer are: * Does CGM-guided diabetes management lead to a larger decrease in HbA1c from baseline to about 6 months than SMBG-guided management? * Does CGM use increase the time that glucose stays in the target range and reduce low blood sugar episodes, without causing new safety problems? Researchers will compare two groups. One group will use the RIGHTEST iFree 2 CGM system together with a smartphone app to view glucose data in real time. The other group will use standard finger-stick blood glucose monitoring with an approved blood glucose meter as their main tool for checking glucose. Both groups will continue to receive routine diabetes care from their usual health-care providers. Participants will take part in regular clinic visits over approximately 6 months. At these visits, study staff will review glucose records, adjust diabetes treatment if needed, and collect information such as HbA1c and other blood tests, device data, and questionnaires about quality of life and diabetes-related distress. Safety information and any device problems will also be recorded. The results will help determine whether CGM can be used as a routine tool to improve long-term blood sugar control in people with diabetes.

Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City

In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.

Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App

The goal of this controlled pre-post-trial is to test the Accu-Chek SmartGuide continuous glucose monitoring (CGM) system and whether its predictive features provide additional benefits for adults with type 1 diabetes or insulin- treated type 2 diabetes. The main questions this study aims to answer are: * Does using the Accu-Chek SmartGuide together with the Predict App change participants' fear of hypoglycemia? * Does the Predict App affect other psychological and behavioral outcomes, such as sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment? * Does the use of the predictive features affect glucose levels and the way participants use and respond to CGM alarms and trend information? Participants will use the Accu-Chek SmartGuide for 6 weeks. During the first 2 weeks, participants will use the CGM system without the predictive features. During the following 4 weeks, participants will use the system together with the Accu-Chek SmartGuide Predict App. Participants will complete online questionnaires at two time points (after 2 and after 6 weeks) and answer short questions twice a day through a smartphone app during the first 2 weeks and the last 2 weeks of the study. CGM data will be collected throughout the study. A subgroup of 10 participants will also be invited to take part in an online interview about their experiences with the predictive features.

Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health (Healthy Heart - CKM)

The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.

Adaptation, Implementation, and Validation of an Innovative eHealth System for the Self-management, Monitoring, and Specialized Remote Medical Care of Patients With Diabetes in the Municipalities of Palermo (Huila) and Suárez (Cauca).

The study corresponds to a controlled, randomized, open-label clinical experiment approved by the Ethics Committee of Universidad Antonio Nariño, with the participation of clinical scientific personnel and technical support from Engineering. The study will include patients over 18 years of age with type 2 diabetes mellitus (T2DM) for at least one year, under follow-up at chronic patient care centers in Palermo, Huila, and Suárez, Cauca. Participants must have Glycosylated Hemoglobin (HbA1c) greater than 7%, i.e. HbA1c ≥7%, measured using BIOHERMES HbA1c, and receive insulin treatment with at least one daily application or have an indication for insulin treatment. In addition, they must have access to a mobile phone with data. Patients with, among other conditions, acute diabetes decompensation, recent history of myocardial infarction or acute coronary syndrome, glucocorticoid use, visual impairment or cognitive deterioration, proliferative retinopathy, amputations or severe peripheral neuropathy, pregnancy or breastfeeding, psychiatric disease, stage 4 or 5 kidney disease, or severe liver disease will be excluded. Potential patients will be identified among those who have been active for at least three months in chronic disease programs. After verifying the eligibility criteria, the study objectives will be explained and informed consent will be requested, including the right to voluntary withdrawal at any time. The study comprises a 14-day selection period and a 180-day treatment period. During selection, baseline clinical data, HbA1c, and incidence of hypoglycemia will be obtained. Subsequently, Participants will be assigned in a 1:1 ratio to the intervention and control groups using a computer-generated random sequence managed centrally by the study server, ensuring allocation concealment with no possibility of modification by the treating physicians. The study will consist of four visits V1, V2, V3 and V4, corresponding to days 0, 15, 105, and 195, respectively. The intervention group will use the eHealth system and will receive training according to the study protocol and user manual. Data recorded on the platform will be evaluated every two weeks by a physician trained in diabetes care, who may make therapeutic adjustments in the event of hypoglycemia or recurrent hyperglycemia, according to established protocols and the ACE 2024 clinical guideline. The system enables the acquisition of data from glucose meters, analysis through a web interface, and remote medical communication through a mobile application. The control group will receive usual care and capillary glucose self-monitoring, with in-person evaluations every three months and therapeutic adjustments according to established protocols. During the visits, blood pressure, weight, HbA1c, medications used, hypoglycemia episodes, home glucose measurements, periods without medication, hospitalizations, and symptoms associated with adverse events will be evaluated. The DTSQs (treatment satisfaction), ADDQoL19 (diabetes-dependent quality of life), and HypoSRQ (self-reported hypoglycemia) questionnaires will also be administered at baseline (V2), 3 months (V3), and 6 months (V4). At 6 months, the DTSQc (change in treatment satisfaction) will be added for both groups, and an adapted version of the Telehealth Usability Questionnaire (TUQ) will be administered to the intervention group. To control possible changes associated with the observation effect, physical activity will be monitored through daily step records and diet through nutritional training and calorie counting at baseline, three months, and six months. Data will be transferred in anonymized form and used exclusively for the research objectives, without commercial purposes. The sample size was calculated to detect a 0.5% reduction in HbA1c, with 80% statistical power, an alpha error of 0.05, and a standard deviation of one. A total of 42 patients per arm in each municipality was estimated and, considering a 10% loss to follow-up, a sample of 50 patients per arm in each municipality was established, for a total of 200 patients.

Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes

The goal of this study is to better understand the real-world effectiveness of semaglutide use on cardio-kidney-metabolic outcomes among adults with T2D and adults with obesity (without diabetes mellitus). This is a retrospective longitudinal analysis using the LMC Diabetes Registry. The primary outcome of the study is to evaluate the change in HbA1c between baseline to 3 years of follow-up among adults with T2D who initiated semaglutide compared to adults with T2D who initiated other AHAs, including sulfonylurea, dipeptidyl peptidase-4 inhibitors, and sodium-glucose cotransporter-2 inhibitors.

Integrating New Skills Into Diabetes Education With CGM

This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program ("intervention") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches ("comparators"). Following a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator 1) will receive a one-time clinic-based CGM training. The second comparator (Comparator 2) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks. The study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention. Lastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.

Awareness of Bidirectional Relation of Diabetes Mellitus and Periodontal Health

The study will recruit patients having diabetes mellitus; where they will be asked to answer a questionnaire after obtaining an informed consent.

Role of Alpha-to-beta Cell Communication to Adapt Insulin Secretion to Insulin Resistance.

Glucagon secretion from α-cells has long been viewed as primarily a counterregulatory mechanism - e.g. an agent with a role to prevent blood sugar from decreasing to levels that compromise function. Our group, along with other researchers, have begun to identify a much more complex role for α-cells, raising questions about when and how glucagon may influence blood glucose levels. This proposal looks to detail proglucagon peptide secretion from α-cells and the impact this has on β-cell function and glucose tolerance, in preclinical studies of human islets and translational studies in human subjects. This protocol registration describes Aim 2 from this NIH grant which involves 2 study populations and separate protocols but addresses a common question. Aim 3 in the grant is focused on a separate hypothesis and will be conducted and published separately from Aim 2.

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Benefits of Retained Insulin for Good Health

The purpose of this research is to understand the impact of retained endogenous insulin (as measured by C-peptide) on quality of life and related outcomes in people living with insulin treated diabetes, and, in those living with type 1 diabetes, to determine the pragmatic and non-pragmatic C-peptide measures which have the strongest association with clinical benefit (including repeated home samples and derived measures of beta cell function). The investigators will do this in two ways: Firstly, the investigators will extend a large existing prospective study of new adult onset diabetes (Getting the Right Classification and Treatment From Diagnosis in Adults With Diabetes (StartRight)) https://clinicaltrials.gov/ct2/show/NCT03737799) which has followed 1800 participants for median 4 years from diabetes diagnosis. Participants with insulin treated diabetes will be invited to take part in a further research visit remotely or face to face. The investigators will assess the longitudinal relationship between C-peptide and the available quality of life, mental health status and healthcare utilisation measures over up to 9 years from diabetes diagnosis and assess additional measures in cross sectional analysis. In the second part of this research, the investigators will utilise cohorts of over 2500 participants with type 1 diabetes, measured C-peptide and consent to recontact to recruit 200 participants with a range of C-peptide. Eligible participants with C-peptide measured in clinical care may also be invited to take part. The investigators will undertake detailed assessment of complex and pragmatic measures of C-peptide and beta cell function and compare performance in predicting glycaemic outcomes (using data from continuous glucose monitors) and (where relevant) patient reported outcomes.

A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).

The Diabetes \& Equine Empowerment Program (DEEP) is a research study evaluating a novel diabetes education program that combines hands-on interactions with miniature horses and evidence-based diabetes self-management education for youth ages 8-20 years with diabetes. Participants and their caregivers attend four structured educational sessions led by a diabetes specialist and a certified equine specialist. Topics include diabetes self-management, coping skills, problem-solving, self-advocacy, and transition readiness. Researchers will evaluate whether the program is feasible to deliver, acceptable to participants and families, and helpful in supporting engagement in diabetes care. Participants will be followed for up to six months after the program, and study outcomes include satisfaction, diabetes-related distress, self-care behaviors, clinic attendance, and diabetes technology use. In simple terms, this study is exploring whether learning about diabetes through guided activities with miniature horses can help children, adolescents, and young adults feel more confident in managing their diabetes, improve self-care skills, and become more engaged in their health care. The goal is to determine whether this innovative educational approach is practical to offer and valued by patients, families, and health care providers.

Holistic CRM Care vs Standard of Care in a Primary Care Setting

Cardiovascular disease, high blood pressure, chronic kidney disease, and type 2 diabetes, collectively referred to as Cardio-Renal-Metabolic (CRM) conditions, are among the most common chronic diseases in society. In Sweden, approximately 2.5 million people live with high blood pressure, one million have impaired kidney function, and more than half a million live with diabetes or heart disease. Many individuals are affected by more than one of these conditions at the same time, meaning that up to 30% of patients registered at an average primary care practice belong to this group. These diseases are closely interconnected. Developing one condition substantially increases the risk of developing another, and the risk of cardiovascular events and other complications rises sharply as the number of diagnoses increases. As people live longer, it is becoming increasingly common for older adults to live with several chronic diseases simultaneously. This places a considerable burden on healthcare systems, both medically and economically. At the same time, there is strong evidence that early, coordinated interventions can slow disease progression and reduce the risk of future complications. Despite clear national guidelines, there is still room for improvement in clinical practice. One important reason is that healthcare services and treatment guidelines remain largely organized around individual diagnoses rather than around the overall needs of each patient. As a result, different specialists often work in parallel, sometimes pursuing different treatment goals and strategies. This can lead to both under-treatment and over-treatment, contributing to unequal care and unnecessary burden for patients. The CRM Centre at Danderyd Hospital provides an example of how integrated care can work in practice. There, assessment, treatment, and follow-up are delivered by a multidisciplinary team that takes the patient's entire disease profile into account. The model has produced promising results for patients with more complex medical needs. However, the vast majority of people with CRM-related conditions are managed within primary care. This study evaluates a new primary care model that builds on the experience gained from the CRM Centre at Danderyd Hospital. The aim is to bring together all patients with CRM diagnoses within a common care structure and a unified treatment strategy. Participating primary care centres will receive education and access to practical support materials that integrate recommendations from guidelines covering all three disease areas. An important component is strengthened collaboration between primary and specialist care. Participating centres will have opportunities for clinical observerships, multidisciplinary digital case conferences with specialists at Danderyd Hospital, and targeted consultations regarding patients with CRM conditions through the Department of Internal Medicine at Ersta Hospital. The project will be integrated into routine clinical practice without requiring additional patient visits. All patient management will be carried out by the responsible healthcare professionals, supported by the educational programme, clinical tools, and collaboration with specialist services. Using electronic health record data, national registers, and health economic analyses, the study will evaluate whether the model improves the use of evidence-based medications, increases achievement of treatment targets, and enhances cost-effectiveness. Long-term outcomes, including survival and rates of hospital admission, will also be assessed. By bringing together care from multiple perspectives, this project addresses a clear and growing clinical need: providing patients with CRM conditions with more coordinated, effective, and equitable care. The findings are expected to be directly applicable across primary care and could inform future models for managing multimorbidity on a broader scale.

Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D

Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.

Local and Systemic Inflammatory Bone Alterations Related to Dental Implant Survival.

Introduction: Dental implants offer a durable, aesthetic, and functional option for tooth replacement. However, they are not immune to failure. Current literature has highlighted the importance of systemic factors (such as vitamin D deficiency, osteoporosis and hypercolesterolemia) and local factors (such as the presence of nearby periapical infections or implant placement in sites with a history of endodontic failure) that affect bone health. Hypothesis: Bone alterations-whether systemic or local-represent a risk factor for implant failure and peri-implantitis. Objectives: To analyze implant failure and marginal bone loss in patients with local and/or systemic bone alterations compared to patients without such conditions. Methods: Implant failures occurring in patients treated within the Master's Program in Oral Medicine, Surgery, and Implantology at the University of Barcelona (MCIO-UB) over the last 10 years will be analyzed and correlated with bone factors (local and systemic) recorded in their medical histories. Cases lacking the radiographic and clinical data necessary to conduct the study will be excluded. Population: A total of 3,500 implants have been placed, with failure rates ranging from 4% to 8% depending on the techniques used; consequently, the study sample will consist of 192 implants. Cohorts of successful implants will be established by matching patients of the same sex and within a ±5-year age range who did not experience implant failure.

MiniMed Fit Payload Wear Pediatric Study

The purpose of this study is to assess MiniMed Fit Payload adhesive components in different wear locations over a 7-day period to support development of the future commercialized patch pump in participants 7-17 years of age.

An Innovative Proprioceptive Instrument for Upper Extremities

This study aimed to develop and validate an innovative proprioceptive assessment instrument for the upper extremities, the PropArm-PosiMoF (PropArm). This observational study was conducted in three stages. The first stage focused on the development and validation of PropArm, including test-retest reliability, concurrent validity, and convergent validity. The second stage established age norms and cut-off points in healthy adults. In the final stage, PropArm was applied to patients with proprioceptive impairments (stroke, shoulder impingement syndrome, and diabetes mellitus patients) to examine its diagnostic accuracy and clinical applicability.

Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes

This is a prospective, multicenter, randomized, double-blind, sham-controlled, adaptive study evaluating the pulsENDO system in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications (GLMs). The primary objective of this study is to demonstrate that pulsENDO therapy is superior to sham control for improving glycemic control in adults with type 2 diabetes.

Impact of Online Medical Misinformation

A cross-sectional analytical study was conducted among adult patients diagnosed with chronic diseases to assess the impact of online medical misinformation on medication adherence, treatment decision-making, and health care-seeking behavior.

Pilot RCT of a Chinese Medicine Diabetes Education Programme

The goal of this clinical trial is to learn if a Chinese medicine diabetes education programme is feasible and acceptable, and to explore its preliminary effects on self-management, for adults with type 2 diabetes in Hong Kong. The main questions it aims to answer are: 1. Is the Chinese medicine diabetes education programme feasible to deliver in a community setting (recruitment, retention and adherence)? 2. Is the programme acceptable to participants? 3. Does the programme show early signals of improving diabetes management self-efficacy and related outcomes? Researchers will compare the Chinese medicine education programme to usual care to see if the programme is feasible, acceptable and shows preliminary benefits. Participants will: 1. Be randomly assigned to either a 4-week Chinese medicine diabetes education programme (four group sessions, total 4-6 hours) or usual care 2. Complete assessments at baseline, after the programme, and at 2-month follow-up. 3. Attend a focus group interview at the end of the study (selected participants) Outcome assessors will be blinded to group allocation.

Impact of Food as Medicine Glycemic Control at Two Large Academic Medical Centers

The primary purpose of this study is to determine if the implementation of a food as medicine program would improve clinical outcomes when integrated into routine care at two large academic hospitals. 1. Determine if the FRESH Program's methods of addressing food insecurity improves clinical outcomes, reduces emergency room visits, and reduces hospital admissions for patients with diabetes, cardiovascular disease, surgery, and/or recent COVID-19 hospital admission. 2. Determine the feasibility and scalability of the FRESH Program nutrition intervention within two separate health systems in order to inform future state and federal policies governing reimbursement for nutritional interventions that improve food insecurity.