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37 recruiting in MA
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Diabetes Body Project 2

Eating Disorders · Type 2 Diabetes

The purpose of this study is to test the feasibility and effectiveness of an eating disorder prevention program specifically targeted for women with type 2 diabetes (T2D) called the Diabetes Body Project 2 (DBP2). The Diabetes Body Project 2 (DBP2) will be adapted from the Diabetes Body Project, which is an eating disorder prevention program developed to improve satisfaction with body image and diabetes management for young women with type 1 diabetes (DBP). The study is looking to see if the DBP is effective in improving body image concerns, reducing disordered eating behaviors and improving glycemic control in women with T2D.

Boston, MA18–40 yrsWomen
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Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems

Peripheral Neuropathies · Peripheral Neuropathy Due to Chemotherapy · Peripheral Neuropathy With Type 2 Diabetes

The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. The main question it aims to answer is whether participants who use Walkasins on an everyday basis over a six-month period will report better awareness of their foot placement on the ground. Researchers will compare Walkasins users to a control group of participants who are not using Walkasins to see if the device improves the users' performance on some standing and walking tests. Control group participants will get Walkasins after six months of being in the study. During the study participants will be asked to do the following: * Answer questions about their medical history and balance. * Do some standing and walking tests. Some of the tests will be timed. * Attend study visits and participate in study phone calls. * Keep track of any falls and notify study staff if they fall. * Wear the Walkasins device on a regular basis.

Boston, MA55+ yrsAll genders
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KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases

Mitochondrial Diseases · Maternally Inherited Diabetes and Deafness (MIDD) · Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like Episodes (MELAS)

The KHENERFIN study aims to determine whether the study medicine, sonlicromanol, is able to reduce symptoms of fatigue and the impact of fatigue on daily life, and whether sonlicromanol is able to improve physical abilities of people like balance control and lower limb skeletal muscle strength in people with mitochondrial disease. In this study, the effects of sonlicromanol are compared against a placebo, a tablet identical in appearance and taste but without the active drug. Participants take either sonlicromanol or placebo twice daily for a treatment duration of 52 weeks. In addition to these primary objectives, the study evaluates the efficacy of sonlicromanol on secondary and exploratory outcomes, as well as its safety and tolerability after one year of treatment.

Boston, MA18+ yrsAll genders
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Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial

Obesity · Liver Diseases · Liver Fibrosis

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD/metabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery. Over the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown. In this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.

Boston, MA18+ yrsAll genders
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Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships

Diabetes Mellitus, Type 2

The goal of this study is to develop, implement, and evaluate a patient-centered triage and referral model designed to improve health outcomes for individuals with uncontrolled type 2 diabetes mellitus (T2DM) and unmet health-related social needs. The intervention builds on the existing THRIVE infrastructure at Boston Medical Center (BMC), which includes screening for social needs and a resource referral guide. It integrates medical and social care by embedding a data-driven triage tool within the EPIC electronic health record system, engaging community health workers trained in population health, and initiating closed-loop EPIC integrated referrals to community-based organizations. This study will use a hybrid type 3 effectiveness-implementation trial design to evaluate the implementation of the THRIVE-DM intervention at the clinic level. Preliminary effectiveness will be assessed by comparing THRIVE-DM to usual care in its ability to increase patient connections to community-based organizations and improve clinical outcomes. Using a stratified randomization approach, the investigators will compare referral closure rates, receipt of social services, hemoglobin A1C levels, and patterns of health service utilization between patients enrolled in THRIVE-DM and those receiving standard care

Boston, MA18+ yrsAll genders
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Continuous Glucose Monitor Use in Pregnancy

Type 2 Diabetes Treated With Insulin · Pregnancy, High Risk

The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

Worcester, MA18+ yrsWomen
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Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Type 2 Diabetes · Cortisol Excess

CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment).

Springfield, MA18+ yrsAll genders
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A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

Obesity · Overweight

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.

Quincy, MA18+ yrsAll genders
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EVOC - EVs in Obesity and Cardiometabolic Disease

Cardiovascular Diseases

The goal of this observational study is to research the impact of molecular signals from the heart, liver and fat tissue on cardiovascular disease risk, and the presentation of Type II Diabetes and diseases that affect the heart, blood vessels and metabolism (Cardiometabolic Disease). Specifically, the focus is on the content and function of Extracellular Vesicles (EVs), small sacs released from a cell's surface that contain important molecular cargo. The main questions it aims to answer are: 1. What molecular cargo do adipose-tissue EVs carry? 2. How do these cargo impact cardiac and hepatic function? 3. Are changes in EV content related to cardiac function and adiposity with weight loss? Tissue samples from fat tissue and blood samples will be collected from patients receiving bariatric weight loss surgery.

Boston, MA18+ yrsAll genders
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Improving Coronary Vascular Health in Women

HIV-1-infection · Coronary Microvascular Dysfunction · Metabolic Disease

Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV. One of the mechanisms underlying the increased risk of myocardial infarction among women with HIV may involve reduced ability to increase blood flow through large and small coronary arteries at times when increased flow of oxygen-carrying blood is needed. We are conducting a study randomizing women with HIV and either diabetes, chronic kidney disease, or both to health education alone or to health education plus referral to see either an Endocrinologist or a Nephrologist in a subspecialty clinic for consideration of treatment with medication in a class known as sodium glucose transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors are clinically approved for use in patients with diabetes or chronic kidney disease but have been shown to be underutilized in people with HIV. One of our key analytic aims will be to test if SGLT2 inhibitor therapy results in improved blood flow through the large and small coronary arteries among women with HIV and either diabetes, chronic kidney disease, or both but who have no history of myocardial infarction. A second aim will be to test if subspecialty clinic referral (with or without SGLT2 inhibitor therapy prescription) results in improved blood flow through the large and small coronary arteries among the same group.

Boston, MA45–75 yrsWomen
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Boosting Emotional Well-being and Happiness in Outpatients Living With Diabetes

Diabetes Mellitus, Type 2

The focus of this study is to test the efficacy of an 8-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks), compared to MI-alone, in a randomized trial of 280 individuals with type 2 diabetes and low baseline physical activity.

Boston, MA18+ yrsAll genders
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Gastroparesis Registry 4

Gastroparesis · Gastroparesis Nondiabetic · Gastroparesis Due to Diabetes Mellitus Type I

The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.

Boston, MA18–85 yrsAll genders
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A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin

Overweight · Obesity

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy. Participation in the study will last about 80 weeks.

Boston, Waltham, MA18+ yrsAll genders
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Vitamin D and Type 2 Diabetes - Treat-To-Target

Prediabetes · Type 2 Diabetes (T2DM)

This study tests whether taking a weekly dose of vitamin D, with the dose adjusted to reach a target blood vitamin D level, can help control blood sugar levels in adults at high risk of developing type 2 diabetes (prediabetes). Research suggests that vitamin D may play a role in blood sugar control. The goal of this study is to see whether adjusting the dose of vitamin D to reach a specific blood vitamin D level improves blood sugar control compared with a placebo (a look-alike pill without vitamin D). One hundred adults aged 30 to 74 with prediabetes will take part. Participants will be randomly assigned (by chance) to receive either weekly vitamin D supplements or a placebo. Neither the participants nor the research team will know which group a participant is in during the study. Participants in the vitamin D group will start with one specific dose. After three months, a blood test will be used to decide whether the dose should stay the same or be increased to reach the target vitamin D level. Participants in the placebo group will continue taking the placebo each week. All participants will be followed for about 18 months. During the study, they will attend scheduled study visits, have blood tests, and wear a continuous glucose monitor, a small device that measures blood sugar levels throughout the day and night. The research team will also make periodic phone calls to check on health changes, medication use, and study participation. The main outcome of the study is the proportion of time that the participants' blood sugar levels remains in a healthy range.

Boston, MA30–74 yrsAll genders
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A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight

Overweight · Obesity

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 weeks.

Needham, New Bedford, MA18–75 yrsAll genders
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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

Diabetes Mellitus, Type 2 · Hypertension · Cardiovascular Diseases

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.

Malden, Methuen, MA18+ yrsAll genders
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