GLP-1 Analogue Therapy for Cardiometabolic Risk in Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of 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. Investigators aim to obtain reference data for individuals with T1D who do not have overweight obesity, to understand how close GLP-1 analogue obesity treatment in those with overweight/obesity brings physiologic markers of cardiometabolic risk to those with BMI in the normal range. Specifically, investigators will describe how drivers of gluconeogenesis and lipemia (specifically measured as visceral fat ratio, insulin resistance, and postprandial lipemia,) that contribute to cardiometabolic risk in T1D change over time.
Will I have to stop taking my current medications?
The trial requires that you do not use any adjunctive diabetes medication or anti-obesity medication, and you cannot use lipid-lowering medications other than statins or omega-3 products. If you are on these medications, you may need to stop them to participate.
Is GLP-1 Analogue Therapy safe for humans?
How does the drug GLP-1 Analogue Therapy differ from other treatments for cardiometabolic risk in type 1 diabetes?
GLP-1 Analogue Therapy, using drugs like Victoza and Saxenda, is unique because it targets the GLP-1 receptor to improve insulin release and reduce glucagon (a hormone that raises blood sugar) secretion, which can help manage blood sugar levels and reduce cardiovascular risks. Unlike traditional insulin therapy, these drugs also help with weight loss and have a positive impact on heart health, making them a novel option for managing cardiometabolic risks in type 1 diabetes.678910
What data supports the effectiveness of the drug GLP-1 Analogue Therapy for reducing cardiometabolic risk in Type 1 Diabetes?
Research shows that GLP-1 receptor agonists, like those used in the treatment, can help reduce cardiovascular risk factors such as body weight, blood pressure, and cholesterol levels in people with Type 2 diabetes. These benefits may also apply to people with Type 1 diabetes, potentially improving heart health.67111213
Who Is on the Research Team?
Michelle Van Name, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for young adults aged 18-30 with Type 1 Diabetes who are not overweight, use continuous glucose monitoring, have an HbA1c level ≤10%, and no severe kidney or liver issues. They must be willing to follow the study procedures for its duration and cannot be pregnant, lactating, or planning pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments including abdominal MRI, hyperinsulinemic-euglycemic clamp with stable isotope tracer, DEXA scan, and a High Fat Mixed Meal Tolerance Test
Monitoring
Participants are monitored for changes in visceral adipose tissue, hepatic insulin resistance, and triglycerides over 1 year
Follow-up
Participants are monitored for safety and effectiveness after the main study period
What Are the Treatments Tested in This Trial?
Interventions
- High Fat Mixed Meal Tolerance Test
- Hyperinsulinemic-euglycemic clamp
High Fat Mixed Meal Tolerance Test is already approved in European Union, United States, Canada, Japan for the following indications:
- Type 2 diabetes
- Obesity
- Type 2 diabetes
- Obesity
- Type 2 diabetes
- Obesity
- Type 2 diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator