Health TrialsbyHealthPanel

Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment

ConditionsDiabetes type1Obesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-30
SponsorYale University

About this trial

More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events. GLP-1 analogues are anti-obesity medications that are cardioprotective in adults with type 2 diabetes, however evaluation of these agents in people with T1D has been limited to glycemic outcomes. Investigators aim to study the impact of GLP-1 analogue obesity treatment on markers of cardiometabolic risk in young adults with T1D and obesity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-30 years with T1D whose BMI meets FDA approval criteria for anti-obesity pharmacotherapy (BMI ≥30 kg/m2 alone or BMI ≥27 kg/m2 with a weight-related comorbidity)

Clinical diagnosis of T1D

Diabetes duration diagnosed ≥ 12 months ago

HbA1c ≤10% at screening and within the past 90 days

Disqualifiers

Use of adjunctive diabetes therapies or anti-obesity medications (including any GLP-1 agonist) currently or within the past 6 months.

Insulin dosing <0.5 units/kg/day

Current psychiatric conditions impacting weight, including known eating disorders

Personal history of pancreatitis, renal impairment, or known liver disease other than non-alcoholic hepatic steatosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide Pen Injector

    Drug

    Escalated to 2.4mg or max tolerated dose

  • Placebo

    Drug

    Matched placebo.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: SemaglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in VAT/(VAT+SAT) from baseline to 12 months

Measured as VAT/Subcutaneous Adipose Tissue + VAT changes over 1 year.

Time frame
baseline and 12 months
2

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.

Time frame
baseline and 12 months
3

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.

Time frame
baseline and 12 months

Secondary outcomes

1

Change in weight from baseline to 12 months

Mean change in weight (kilograms) assessed using a scale

Time frame
baseline and 12 months
2

Change in percent body fat from baseline to 12 months

Mean change in percent body fat assessed using DEXA scan measurements

Time frame
baseline and 12 months
3

Change in BMI from baseline to 12 months

Mean change in BMI calculated using measured height and weight.

Time frame
baseline and 12 months
4

Change in mean glucose concentration

Change in mean glucose concentration. Data collected as available using participant's personal clinical continuous glucose monitor.

Time frame
baseline and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Novo Nordisk A/S

Collaborator

Source ClinicalTrials.gov
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