Clinical Research Directory

A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin

The purpose of this study is to evaluate efficacy and safety of once-weekly SHR-3167 and once-daily Insulin Degludec in participants with Type 2 diabetes that has been treated with basal insulin. The study consists of a screening period, a treatment period and a safety follow-up period. The study will last up to 33 weeks.

A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event

The purpose of this study is to measure the change in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body, with clazakizumab compared with placebo in adults who have elevated hsCRP and at increased risk for cardiovascular event. Participation in the study will last about 9 months.

Food As MedicinE for Diabetes

The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). While the efficacy of MTM needs to be established, given the nature of the population served by MTM, it is important to design the study to enhance the external validity/generalizability of the findings as much as possible. The investigators will recruit 200 participants from the referral list of Community Servings, a Boston-based MTM provider, and randomly assign them to MTM (N=100) or usual care + monthly food subsidy (N=100). MTM intervention will consist of 6 months of weekly delivery of 10 ready-to-eat meals (approximately half an individual's weekly food intake), along with telephone-based lifestyle intervention that prepares participants for the post-treatment period. The usual care + food subsidy recipients will receive usual care along with 6 months of a $40/month food subsidy.

Chrono Nutrition and Insulin Resistance in Diabetes

The goal of this randomized clinical trial is to determine the effect of a chrono nutrition intervention compared with a usual dietary intervention on insulin resistance in individuals with type 2 diabetes with overweight or obesity over a 6-month period. The main question it aims to answer is: What is the effect of a chrono nutrition intervention compared to a standard intervention on insulin resistance in individuals with T2D (type 2 diabetes) with overweight or obesity over a 6-month period? Participants: * Will be asked to fast for 12 hours each day. During the fasting period, they may consume non-caloric beverages such as plain water, coffee, or unsweetened tea. * They will be asked to follow a dietary plan in which the total daily calorie intake will be calculated using indirect calorimetry, subtracting 500 calories from the total calorie amount. * The dietary plan will have the following macronutrient distribution: 40% carbohydrates (\<10% simple carbohydrates), 20% protein, and 40% fats (6-11% polyunsaturated, 15-20% monounsaturated, and \<10% saturated). * The plan will consist of 3 meals: breakfast will account for 40% of the total calories. Dinner will include only 10% of the total grams of carbohydrates. * The order of food consumption should be: 1) vegetables, 2) proteins, 3) complex carbohydrates, and 4) simple carbohydrates (fruits). Researchers will compare the chrono nutrition strategy with a standard dietary intervention to see the effect in insulin resistance.

The Impact of Nicotinamide Mononucleotide Sustained-release Tablets on Immunosenescence and Metabolism in Middle-aged and Elderly Individuals With Metabolic Disorders.

This study evaluates whether nicotinamide mononucleotide (NMN) sustained-release tablets affect markers of immune system aging in adults aged 50 to 70 years with overweight or obesity and metabolic disorders. It compares NMN, 1,000 mg once daily for 26 weeks, with a matching placebo. The main assessment is the change from baseline in the proportion of a blood T-cell population associated with immune system aging. The study also evaluates liver fat, blood sugar regulation, body composition, other immune and metabolic markers, and cardiorespiratory fitness, together with laboratory measures of safety.

A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, Type 2 Diabetes, and Increased Cardiovascular Risk

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with a placebo in participants with obesity or overweight, type 2 diabetes, and increased cardiovascular risk.

A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes

The purpose of this study is to investigate the efficacy and safety of eloralintide and tirzepatide coformulation (EloraTZP) compared to tirzepatide for body weight reduction in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 2 years.

Decreasing Cardiovascular Risk for Patients With Diabetes

Cardiovascular disease (CVD) complications are the leading cause of diabetes mellitus (DM)-related morbidity and mortality, creating a significant burden on the public health system. This burden is, in part, attributable to poor medication adherence, with 21-42% of patients failing to properly adhere to their care. Importantly, this issue is especially pronounced in minority and low-income populations, which show higher rates of chronic illness and lower medication adherence. Interventions that foster and reinforce patient-centered communication between clinicians and patients show promise in improving health outcomes. However, they have not been widely implemented, in part due to a lack of compelling evidence for their effectiveness in primary care settings. Project Objective: The investigators propose to evaluate the impact of a patient activation program: Office Guidelines Applied to Practice (Office-GAP) combined with mobile text messaging reinforcement (Way to Health \[W2H\]) on medication adherence in patients with DM compared to mobile texting alone. Office-GAP incorporates shared decision-making and a decision/support checklist to be completed during office visits, to foster patients' investment in their own care. W2H is a texting service that informs and encourages patients to adhere to goals and improve communication. The long-term goal is to develop a model that can reliably improve and sustain adherence and can be successfully implemented in primary care clinics to close the morbidity and mortality gap for minority/low-income DM patients. The hypothesis is that the combined face-to-face patient activation and texting- delivered reinforcement methods will facilitate communication between patients and providers, improving the frequency, accuracy, and timeliness of communication while reinforcing shared goals and engendering mutual respect more than texting alone. Improved communication between patients and providers may improve medication adherence, blood sugar, cholesterol, blood pressure control, and patient satisfaction with providers, and ultimately decrease burden of illness. Research Strategy: The investigators will conduct a randomized community-based clinical trial in Federally-Qualified Health Centers (FQHCs) in Michigan enrolling 378 patients in 17 teams. All patients will receive usual care and medication for DM and CVD prevention. Eight teams will use W2H alone, and 9 teams will combine Office-GAP with WTH. The investigators will evaluate the impact of shared decision-making strategies for patients and providers. Impact: If successfully translated to clinical practice, these interventions have the potential to significantly impact patient care in FQHCs, improving outcomes for DM and CVD. This research also paves the way for shifting clinical practice across a spectrum of chronic disease where medication non-adherence is an issue.

RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study

This study will evaluate the accuracy and safety of the RIGHTEST iFree 2 Continuous Glucose Monitoring (CGM) System in pregnant women with type 1 diabetes, type 2 diabetes, or gestational diabetes. The system uses a small sensor placed under the skin to measure glucose levels in the fluid between cells. Approximately 104 women will participate at study sites in Germany and Taiwan. Each participant will wear two sensors, one on each upper arm, for up to 15 days. During one clinic visit lasting up to six hours, blood samples will be collected every 15 minutes. Sensor readings will be compared with laboratory blood glucose measurements to assess accuracy. Participants will also be assessed for side effects, including skin reactions at the sensor sites, and will receive a safety follow-up after sensor removal. No procedures will be used to deliberately raise or lower blood glucose levels.

Cross-Sectional and Longitudinal Studies of "Pre-Diabetes" in the Pima Indians

Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes. These results suggest that both inherent (apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and environmental determinants of diabetes we are continuing to determine: (1) if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion. \<TAB\> Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition, oral and intravenous glucose tolerance and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues. A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity, insulin secretion, insulin resistance and/or type 2 diabetes.

Mechanisms of Diabetic Kidney Disease in American Indians

Background: \- An ongoing study is looking at American Indians who have kidney problems caused by type 2 diabetes. Kidney disease due to type 2 diabetes is a major problem in American Indians. We previously found that early treatment of kidney disease with losartan was probably beneficial for reducing progression of the disease. Researchers now want to see if these benefits continue to be seen several years after the end of the treatment study. Objectives: \- To study long-term benefit of losartan treatment for diabetic kidney disease in American Indians with type 2 diabetes. Eligibility: \- Participants in the American Indian diabetic kidney disease study (OH95-DK-N037). Design: * Participants will have a physical exam and medical history before starting the study. Blood and urine samples will be collected. * Participants will have a set of tests as part of this study. Those who have severe kidney problems, such as kidney failure, will only have a basic kidney exam with scans. The remaining participants will have a full urine collection and analysis. They will also provide a kidney biopsy. * Treatment will not be provided as part of this study.

Molecular and Clinical Profile of Diabetes Mellitus and Its Complications

Background: \- Family and twin studies have suggested that genetic factors influence approximately 50 percent of a person's susceptibility to type 2 diabetes. Recently, some of the genes involved in the development of type 2 diabetes have been identified, in large part by genome-wide association studies. Certain risk factors for type 2 diabetes, such as obesity and insulin resistance, are highly inheritable, as are diabetic complications such as diabetes-related eye and kidney disorders. However, few genes associated or linked with diabetes risk factors or complications have been conclusively identified, and more research is needed to study specific genetic factors associated with these aspects of diabetes. Objectives: \- To identify and characterize genetic variants associated with type 2 diabetes, its risk factors, and its complications. Eligibility: \- Individuals at least 18 years of age who are not pregnant or nursing mothers at the start of the study. Design: * All participants will provide information about family history, ethnicity and ethnic background, occupation, behavioral risk factors, and other data as requested by the researchers. * In addition to a general health history, participants will provide specific information about diabetes history, with particular emphasis on date of diagnosis, symptoms, initiation of insulin therapy, complications, and current medications. * Testing procedures will be different for individuals with and without diabetes. Those without diabetes will have an oral glucose tolerance test, while those with diabetes will be examined for diabetic complications. * Other tests during the study will include the following: * Physical examination with measurements of height and weight, waist circumference, blood pressure, and other tests for individuals who have been diagnosed with diabetes * Glucose tolerance test for those who have not been classified as having diabetes * Retinal photographs * Electrocardiograms * Hepatic Ultrasound * Blood and urine tests * Depending on the results of the examination and laboratory findings, participants may be asked to return to the clinic for supplemental interviews, physical examinations, or blood tests, or to arrange referrals for medical evaluation and treatment. * Participants who have diabetes will be asked to return for yearly follow-up visits. Participants who do not have diabetes at the initial examination will be asked to return for follow-up visits every 2 years.

Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer

Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice. Primary objective of the study: \- identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus; Secondary objectives of the study: * description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus; * assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes; * assess the relationship between the characteristics of patients and the time to the onset of cancer.

Prospective Studies of the Natural History of Diabetes Mellitus and Its Complications in the Gila River Indian Community

This project is a continuation of an extensive longitudinal population-based epidemiological investigation of the etiology and determinants of type 2 diabetes (and its complications) and formerly arthritis. The original baseline observations were made on the residents of the Gila Indian Reservation, predominantly Pima Indians, in 1965. We attempt to reexamine the population at two-yearly intervals, and have continued to recruit new respondents who, because of age and residence or familial relationships, become eligible for entry into the project. Eligible persons receive a battery of standardized examinations related to diabetes and its complications at two-yearly intervals, including a glucose tolerance test, biochemical determinations, such as serum cholesterol and creatinine, insulin, etc., a physical examination, and in those aged 15 years and above, retinal photographs, and an electrocardiogram. Persons known to have diabetes will be asked to undergo the examination at annual intervals to enable more complete and accurate documentation of their health status and to identify the development and progression of complications of the disease. The data collected have been used to describe the natural history and determinants of diabetes and its complications, to investigate factors relating to the etiology of these diseases and investigate the genetics of diabetes, its complications and other phenotypes. In addition, the project serves to identify subjects with specific characteristics for the clinical research projects carried out by the Obesity and Diabetes Clinical Research Section and the Diabetes Epidemiology and Clinical Research Section fo the Branch.

A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment

Information-Based Interventions for Influenza Vaccination Among Older Adults With Diabetes in Yangzhou, China

Influenza can cause serious illness in older adults, particularly those with diabetes. Although influenza vaccination is an important preventive measure, vaccination uptake among older adults in China remains low. This study aimed to evaluate whether different ways of presenting influenza vaccination information could encourage vaccination among older adults with diabetes in Yangzhou, China. Adults aged 60 to 75 years with diabetes were assigned to one of four study groups: a control group without intervention text messages, a standard information group, a gain-framed information group emphasizing the benefits of vaccination, and a loss-framed information group emphasizing the potential negative consequences of not being vaccinated. The primary outcome was influenza vaccination uptake during follow-up. Secondary outcomes included willingness to receive influenza vaccination and vaccine literacy. The study examined whether information-based interventions could improve vaccination-related outcomes compared with the control group.

EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.

AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults

The goal of this observational cohort study is to delineate the five-year dynamic trajectories of metabolic phenotypes in Chinese adults with overweight or obesity, with or without type 2 diabetes, focusing on transition rates from metabolically healthy overweight/obesity to unhealthy overweight/obesity or to type 2 diabetes, as well as the incidence and progression of diabetic complications and cardiovascular events in those with type 2 diabetes and overweight/obesity. Researchers will compare three phenotype groups, namely metabolically healthy overweight/obesity, metabolically unhealthy overweight/obesity, and type 2 diabetes with overweight/obesity, to assess differences in metabolic parameter changes, complication rates, and cardiovascular risk. Participants will use a digital health management platform for data upload and lifestyle support, and will complete comprehensive health assessments at baseline, at 2.5 years, and at 5 years, along with annual light follow-ups.

Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources

The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO diet high in saturated fat (KETO-Sat) and low-fat diet (LFD) in adults at high risk of or diagnosed with type 2 diabetes. The main question\[s\] it aims to answer are: * Effects on CVD risk factors (plasma cholesterol, TG, ApoB100, glucose, insulin and HbA1C). * Effects on systemic inflammation and immune function. * Adherence to interventions. Participants will be randomized into 1 of the dietary treatments during which they will follow a Keto or a low-fat diet. Comparisons among groups at 3 and 6 months of intervention will be conducted.

A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes

The purpose of this clinical study is to determine if the study medicine NNC9836-0001 is safe and tolerable in healthy participants with overweight or obesity or who have type 2 diabetes (T2D). Participants will either get the study medicine NNC9836-0001 or placebo. Which treatment participants get is decided by chance. NNC9836-0001 is a new medicine aimed to treat type 2 diabetes.

Effects of Nurse-Led Diabetes Education and Telephone Follow-Up in Newly Diagnosed Type 2 Diabetes

This randomized controlled trial evaluated the effects of nurse-led diabetes self-management education supported by telephone follow-up on diabetes knowledge, self-management behaviors, and glycemic control in adults newly diagnosed with type 2 diabetes. Participants were randomly assigned to an intervention group or a control group. The intervention group received structured diabetes self-management education and two follow-up telephone calls at the first and second months to reinforce the education and support self-management. The control group continued to receive routine clinical care without additional structured education or telephone follow-up from the research team during the study. Diabetes knowledge and self-management behaviors were assessed at baseline and at three months. Glycemic outcomes, including HbA1c, fasting blood glucose, and postprandial blood glucose, were assessed at baseline and at the first and third months. The study aimed to determine whether combining structured education with telephone follow-up could improve diabetes self-management and blood glucose control during the early period following a type 2 diabetes diagnosis.

Diabetes Toolkit at Discharge

The purpose of this randomized clinical trial is to implement the DM Discharge Toolkit into hospital discharge and assess the effect of the DM Discharge Toolkit on patients newly requiring insulin.

Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid

Overweight and obesity are rising in prevalence and becoming a growing threat to public health. Obesity is associated with an increased all-cause mortality, impaired quality of life, and numerous of disorders. Therapeutic strategies against obesity - which include an abundance of dietary and physical training programmes and pharmaceutical drugs to increase energy expenditure or limit appetite or gastro-intestinal fat absorption - have shown limited success on long term weight loss. Thus, overweight and associated conditions is becoming the new normal and there is a need for better understanding gut-to-brain signalling, hormonal and metabolic disturbances in overweight individuals. The purpose of this health science research project is to describe the coinciding plasma and cerebrospinal fluid (CSF) profiles of selected biomarkers after co-ingestion of a meal and model pharmaceuticals in patients with overweight and/or type 2 diabetes compared to healthy control individuals.

Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients

The purpose of this clinical study is to explore structural and functional imaging and systemic biomarkers of diabetic retinopathy (DR) progression, in eyes from Type 2 Diabetes (T2D) patients with moderate to severe non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (PDR) using state of the art methodologies, commonly applied in clinical practice, over a period of two years. This study will provide longitudinal data to better understand retinal changes in moderate to severe diabetic retinopathy and early proliferative diabetic retinopathy and help guide timely interventions to prevent vision loss. One or two eligible eyes per participant may be included in the study. The study will evaluate retinal vascular closure, ischemia, leakage, neurodegeneration, macular edema and microaneurysm dynamics and their association with disease progression.