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

Recruiting now

Conditions studied: Obesity, Type 2 Diabetes

In brief

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. ...

Key facts

Study ID: NCT06730113
Run by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
People needed: 930
Starts: 2025-03-12
Expected to finish: 2033-10-31
Last updated by the study team: 2026-08-05

Who can join

Age: 12 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

An individual who meets any of the following criteria for their specific group will be excluded from participation in this study:
Y-T2DM, Y-OW and Y-Lean Participants:
1a. Type 1 diabetes or the presence of >2 diabetes auto-antibodies (e.g., GAD-65, IA-2 antigen, Zinc transporter 8 autoantibodies).
b. Medical, psychiatric or cognitive disorders that will, in the opinion of the investigators, limit the subject s ability to comply with study procedures (specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis).
1c. Serious medical illnesses or diseases thought to alter metabolism (including moderate to severe renal disease (< 30 mL/min/1.73m\^2), congenital heart disease, Cushing s syndrome, cancer, or other metabolic diseases associated with diabetes or excess weight).
1d. For participants enrolled at the NIH, dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.
1e. Unwilling to comply with all study procedures or to adhere to Lifestyle Considerations throughout study duration.
1f. Pregnancy at the time of the screening visit.
1g. Clinically significant anemia OR Hematocrit below the lower limit of normal for age and sex cutoffs.
h. For Y-OW Participants- Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above.
Y-Lean participants:
In addition to the above exclusion criteria, any Y-Lean participant who meets any of the following additional criteria will be excluded from the study:
2a. Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.
2b. Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g., niacin, fish oil, red yeast rice)
2c. History of diabetes or abnormal glucose tolerance
2d.. Abnormal screening labs, including the following:
i) ALT or AST >2 times the upper limit of normal
ii) Glycosuria
iii) Low eGFR (<90 mL/min/1.73m\^2)Any other abnormality that, in the opinion of the investigator, will increase risk to the subject from participation, or interfere with interpretation of study data
2e. Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above.
Biological Parents
No Exclusion Criteria

Where it is running

Children's National Hospital (CNH) — Washington D.C., District of Columbia, United States (enrolling)
National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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