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Clinical Trial Details

Trial ID: L3823
Source ID: NCT06411210
Associated Drug: Semaglutide Pen Injector
Title: Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes type1|Obesity
Interventions: DRUG: Semaglutide Pen Injector|DRUG: Placebo
Outcome Measures: Primary: Change in VAT/(VAT+SAT) from baseline to 12 months, Measured as VAT/Subcutaneous Adipose Tissue + VAT changes over 1 year., baseline and 12 months|Change in hepatic insulin resistance from baseline to 12 months, Hepatic insulin resistance, measured by serum concentration of beta-hydroxybutyrate (surrogate marker of acetyl-CoA, which regulates gluconeogenesis), changes over 1 year., baseline and 12 months|Change in triglycerides from baseline to 12 months, Change in triglycerides after a high-fat mixed meal tolerance test, expressed as the total Area Under the Curve (AUCTG) over 6 hours from baseline to 1 year., baseline and 12 months | Secondary: Change in weight from baseline to 12 months, Mean change in weight (kilograms) assessed using a scale, baseline and 12 months|Change in percent body fat from baseline to 12 months, Mean change in percent body fat assessed using DEXA scan measurements, baseline and 12 months|Change in BMI from baseline to 12 months, Mean change in BMI calculated using measured height and weight., baseline and 12 months|Change in mean glucose concentration, Change in mean glucose concentration. Data collected as available using participant's personal clinical continuous glucose monitor., baseline and 12 months|Mean time in normal glucose range, Mean time in normal glucose range. Range=70-180 mg/dl and 3.9-10 mmol/L. Data collected as available using participant's personal clinical continuous glucose monitor., baseline and 12 months|Mean time in level 1 and 2 hyperglycemia, high range, Mean time in level 1 and 2 hyperglycemia. Range= \>180, \>250 mg/dL and \>10, \>13.9 mmol/L. Data collected as available using participant's personal clinical continuous glucose monitor., baseline and 12 months|Mean time in level 1 and 2 hyperglycemia, low range, Mean time in level 1 and 2 hyperglycemia. Range= \<70, \<54 mg/dL and \<3.9, \<3.0 mmol/L. Data collected as available using participant's personal clinical continuous glucose monitor., baseline and 12 months
Sponsor/Collaborators: Sponsor: Yale University | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 54
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-16
Completion Date: 2028-06-30
Results First Posted:
Last Update Posted: 2024-07-23
Locations: Yale Pediatric Diabetes Center, Adult and Children's Progam, New Haven, Connecticut, 06520, United States
URL: https://clinicaltrials.gov/show/NCT06411210