Clinical trial

Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes

Active, not recruiting · Phase 1 · 1 countries · Registry ID NCT06105931

Active, not recruitingPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 30 Years
SexAll
Healthy volunteersNot accepted
Conditiontype1diabetes, Obesity

Full registry criteria

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 to ≤30 years * Diagnosed T1D for at least 12 months and with BMI \<25 kg/m2. * HbA1c ≤10% * Clinical use of continuous glucose monitoring (CGM) * Any known laboratory safety parameter consistently outside the below extended laboratory ranges in the past year: 1. Baseline creatinine \>1.0mg 2. Hypertriglyceridemia (\>400 mg/dl) 3. ALT ≥3.5 times the upper normal limit (UNL) Exclusion Criteria: * Current use of adjunctive diabetes medication or anti-obesity medication * Insulin dose \<0.5 units/kg/day * Use of lipid lowering prescription medication other than statins or omega-3 products * Doesn't meet MRI safety criteria or having claustrophobia * Known liver disease other than non-alcoholic steatosis or non-alcoholic fatty liver disease * Known renal impairment * Pregnancy or lactation, or planning to become pregnant during the study period. * Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation. * Treatment with another investigational drug within the past 1 month * Past medical history of or self-reported corn allergy

Treatments and study arms

Hyperinsulinemic-euglycemic clamp

Biological

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.

High Fat Mixed Meal Tolerance Test

Other

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.

Primary outcomes

Change in VAT/(VAT+SAT) from baseline to 1 yearbaseline and 1 year

Measured as VAT/Subcutaneous Adipose Tissue + VAT changes over 1 year in young adults with T1D and body mass index \<25kg/m2.

Change in hepatic insulin resistance from baseline to 1 yearbaseline and 1 year

Hepatic insulin resistance, measured by beta-hydroxybutyrate (surrogate marker of acetyl-CoA, which regulates gluconeogenesis), changes over 1 year in young adults with T1D and body mass index \<25kg/m2.

Change in triglycerides from baseline to 1 yearbaseline and 1 year

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Yale Pediatric Diabetes Research🇺🇸 New Haven, Connecticut, United States