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GLP-1 Analogue Therapy for Cardiometabolic Risk in Type 1 Diabetes

Phase 1
Recruiting
Led By Michelle Van Name, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed T1D for at least 12 months and with BMI <25 kg/m2
Male or female, aged 18 to ≤30 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 year
Awards & highlights

Study Summary

This trial aims to better understand how T1D with overweight/obesity can reduce cardiometabolic risk by studying how their bodies respond to GLP-1 analogue therapy.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests how a high-fat meal and insulin affect heart disease risk markers in people with Type 1 Diabetes by using two tests: a Hyperinsulinemic-euglycemic clamp to assess insulin resistance and a High Fat Mixed Meal Tolerance Test to measure fat levels after eating.See study design
What are the potential side effects?
Potential side effects may include discomfort from the testing procedures such as feeling full or bloated after the high-fat meal test, reactions at the infusion site during the clamp procedure, and general discomfort from blood draws.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had Type 1 Diabetes for over a year and my BMI is under 25.
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I am between 18 and 30 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in VAT/(VAT+SAT) from baseline to 1 year
Change in hepatic insulin resistance from baseline to 1 year
Change in triglycerides from baseline to 1 year

Trial Design

1Treatment groups
Experimental Treatment
Group I: Young adults with T1D who have a body mass index <25 kg/m2Experimental Treatment2 Interventions
Young adults with T1D who have a body mass index <25 kg/m2 will have: abdominal MRI, hyperinsulinemic-euglycemic clamp wtih stable isotope tracer, DEXA scan and a High Fat Mixed Meal Tolerance Test.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperinsulinemic-euglycemic clamp
2013
N/A
~10

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,870 Previous Clinical Trials
2,742,971 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,315,547 Total Patients Enrolled
Michelle Van Name, MDPrincipal InvestigatorYale University
2 Previous Clinical Trials
77 Total Patients Enrolled
~10 spots leftby Jun 2028
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