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Recruiting NCT07891156

Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.

Conditions: Type 1 Diabetes, Overweight , Obesity

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 40
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Location: Research Institute of the McGill University Health Centre Royal Victoria Hospital Montreal Quebec

Summary

The goal of this 24 week double-blinded, randomized, parallel controlled clinical trial is to learn how semaglutide affects body composition in adults with type 1 diabetes and overweight/obesity. The main question to answer is: What effect does Semaglutide have on body composition in adults with type 1 diabetes and overweight/obesity compared to a placebo? Around 40 participants will: * Be randomly assigned to receive semaglutide or a placebo. * Self-administer the treatment drug once per week for 24 weeks. * Complete a series of tests, measurements and questionnaires throughout the study duration. * Attend a remote follow-up visit 4 weeks after the treatment is complete.

Eligibility Criteria

Inclusion Criteria: * Age 18-65 years old * Clinical diagnosis of T1D (type 1 diabetes) for ≥ 1 year, as per clinician judgement. * BMI (Body mass index) ≥ 27 kg/m2 * Use of multi-daily injections or insulin pump therapy. * Use of CGM (continuous glucose monitoring). * Agreement to the use of a highly effective method of birth control in persons of child-bearing age (if sexually active) and active avoidance of pregnancy during the trial. Child-bearing potential refers to participants of the female sex post-menarche who have not reached menopause or have a disclosed medical condition causing sterility (e.g. hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause. * Diabetic retinopathy assessment performed within the last 2 years, as per participant history. Exclusion Criteria: * Pre-existing conditions limiting physical activity, specifically inability to walk for 6 minutes. * Active proliferative diabetic retinopathy requiring surgery or laser/injectable therapy within the last 3 months. \*If a history of proliferative retinopathy is present within the last year, written permission from the eligible participant's ophthalmologist or optometrist is required\* * HbA1c (glycated hemoglobin) ≥ 10% within the last 3 months. * Current use of non-insulin anti-hyperglycemic agents within the last month. * Severe hypoglycemic episode within the last 3 months, defined as an event where glycemia was \< 4 mmol/L, resulting in seizure, loss of consciousness, or need for third-party assistance in treatment. * Diabetic ketoacidosis (DKA) within the last 3 months (DKA refers to the need to present to medical attention and the requirement of intravenous insulin due to ketones) * History of bariatric surgery * Personal history of acute/chronic pancreatitis or gallstone disease without cholecystectomy. * Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2. * Severe impairment of renal function with eGFR \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07891156). StuddyBuddy aggregates publicly available trial information.