Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes

Launched by YALE UNIVERSITY · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the health risks related to heart and metabolic conditions in young adults with type 1 diabetes (T1D), particularly those who are not overweight. Over 40% of young adults with T1D also face challenges with weight, which can increase the risk of heart problems. The researchers aim to gather important health information from individuals with T1D who have a normal weight. They want to see how a treatment called GLP-1, used for obesity, may help improve health markers in those with excess weight, bringing them closer to the health levels of individuals with a normal body weight.

To participate, individuals need to be between 18 and 30 years old, have had T1D for at least a year, and have a body mass index (BMI) below 25, which is considered normal weight. Participants will need to use a continuous glucose monitor to track their blood sugar levels and will be expected to follow all study guidelines throughout the trial. It's important to note that certain health conditions or medications may exclude someone from participating. This trial is currently recruiting participants, and those involved will help researchers learn more about managing cardiometabolic risks in young adults with T1D.

Gender

ALL

Eligibility 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