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RECRUITING
NCT06105931
PHASE1

Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes

Sponsor: Yale University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2023-12-13

Completion Date

2028-06

Last Updated

2025-05-04

Healthy Volunteers

No

Interventions

BIOLOGICAL

Hyperinsulinemic-euglycemic clamp

Hyperinsulinemic-euglycemic clamp will be used to assess insulin resistance. After IVs are placed, participants will be transitioned to intravenous insulin administration for the baseline portion of the study. Stable Isotope Tracer Infusions will assess rates of glucose, lipid metabolism, and beta-hydroxybutyrate turnover during the last 30 minutes of the baseline equilibration period and again during the last 30 minutes of the stepped IV insulin infusion periods.

OTHER

High Fat Mixed Meal Tolerance Test

After a 12 hour overnight fast, baseline levels of the lipoproteins will be drawn. The YCCI Bionutrition Service kitchen will prepare the standardized high-fat meal. Participants will administer their bolus insulin per their home regimen for the carbohydrates in the high-fat meal, and then they will consume the meal within a 15-minute timeframe.

Locations (1)

Yale Pediatric Diabetes Research

New Haven, Connecticut, United States