Actively Recruiting
Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
930
Participants Needed
2
Research Sites
450 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. ...
CONDITIONS
Official Title
Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 25 years
- Diagnosis of type 2 diabetes mellitus by specific blood glucose or HbA1c levels with supporting medical history
- Overweight or obesity defined by BMI percentiles for age and sex (for under 18) or BMI thresholds for adults
- Healthy lean participants with BMI below overweight thresholds and normal HbA1c
- Biological parents of enrolled youth participants
You will not qualify if you...
- Diagnosis of type 1 diabetes or presence of more than 2 diabetes auto-antibodies
- Medical, psychiatric, or cognitive disorders limiting ability to follow study procedures (except certain obesity-related conditions)
- Serious medical illnesses affecting metabolism such as moderate to severe kidney disease, congenital heart disease, cancer, or other metabolic diseases
- Dietary allergies or intolerances preventing consumption of study meals
- Unwillingness to comply with study procedures or lifestyle guidelines
- Pregnancy at screening
- Clinically significant anemia or low hematocrit
- For overweight youth, meeting criteria for type 2 diabetes
- For healthy lean youth, use of most medications (except some topical, vitamins, or hormonal contraceptives), recent use of glucose or lipid altering drugs, history of diabetes or abnormal glucose tolerance, abnormal liver enzymes, glycosuria, low kidney function, or other risks per investigator judgment
- No exclusion criteria for biological parents
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Children's National Hospital (CNH)
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
L
Lilian S Mabundo
CONTACT
S
Stephanie T Chung, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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