RecruitingPhase 1NCT06105931

Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes

Sponsor

Yale University

Enrollment

15 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

Obesity Type1diabetes

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.

Eligibility

Min Age: 18 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is identifying early signs of heart and metabolic risk (cardiometabolic risk) in young adults (ages 18–30) who have type 1 diabetes but appear otherwise healthy, using specialized physiological tests and imaging. The goal is to detect problems early, before symptoms appear. **You may be eligible if...** - You are 18–30 years old - You have had type 1 diabetes for at least 12 months - Your BMI is under 25 kg/m² - Your HbA1c (a 3-month blood sugar average) is 10% or less - You currently use a continuous glucose monitor (CGM) **You may NOT be eligible if...** - You take additional diabetes medications (other than insulin) or weight-loss medications - Your daily insulin dose is less than 0.5 units/kg/day - You have known liver, kidney, or blood disorders - You cannot have an MRI (e.g., metal implants, pacemaker) or have claustrophobia - You are pregnant or planning to become pregnant - You have a corn allergy (relevant to some study materials) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHyperinsulinemic-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.

OTHERHigh 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

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NCT06105931

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