RecruitingNCT06730113

Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study

Youth-onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study


Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment

930 participants

Start Date

Mar 12, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Background: Type 2 diabetes is a disease that affects blood sugar levels. Complications can include heart and blood vessel (vascular) diseases. Rates of type 2 diabetes have tripled in children and young adults over the last 40 years. Vascular diseases are also increasing in young people. Objective: To learn more about factors, including type 2 diabetes, that may cause vascular disease in young people. Eligibility: People aged 12 to 25 years who (1) have type 2 diabetes; (2) are overweight but not diabetic; (3) or are lean and healthy. Biological parents are also needed. Design: Young participants will visit the NIH clinic once a year for up to 25 years. Each visit will take 4 days. Before each visit, participants will wear devices to track their sleep, activity, and blood sugar levels for 7 to 10 days. At each visit, participants will have tests including: Samples: They will provide blood, urine, and stool samples. Heart: They will ride a stationary bike for 6 minutes with stickers applied to their chest. Scans: They will lie on a bed that slides into a tube; the machine will take pictures of the inside of their body. Energy: They will wear a hood over their head to measure the air they breathe. Social stress: They will give a speech for 10 minutes to show their body s response to stress. Glucose: They will drink a sweet drink to see how their blood sugar changes. Biological parents will have 1 study visit. They will have blood tests. They will fill in questionnaires about their lifestyle and stress. ...


Eligibility

Min Age: 12 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is following young people (ages 12-25) with type 2 diabetes, overweight/obesity, or healthy weight to understand how early-onset type 2 diabetes affects the heart over time. It will compare how heart health differs between these groups and with their biological parents. **You may be eligible if...** - You are between 12 and 25 years old - You fit into one of these groups: have type 2 diabetes, are overweight/obese (with or without prediabetes), or have a healthy weight (as a control) - Biological parents of enrolled participants are also eligible **You may NOT be eligible if...** - You have type 1 diabetes or more than 2 diabetes-related autoantibodies - You have a serious medical or psychiatric condition that limits your ability to follow study procedures - You have congenital heart disease, cancer, moderate-to-severe kidney disease, Cushing's syndrome, or other conditions that affect metabolism - You are pregnant at the time of screening - You have dietary allergies or eating patterns that would prevent you from consuming study meals (for NIH site participants) - Healthy control participants who are on prescription medications (with some exceptions) are excluded 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.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(2)

Children's National Hospital (CNH)

Washington D.C., District of Columbia, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06730113


Related Trials