NCT06730113Recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Sept 2026

Brief summary (registry, in English)

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. ...

Status (registry): Recruiting
Study type: Observational
Enrollment: 930 (estimated)
First submitted: 11 Dec 2024
Start date: 12 Mar 2025
Primary completion date: 31 Oct 2033
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diseases: Obesity, Type 2 diabetes
NCT number: NCT06730113

What you commit to

Study type: Observational
Planned participants: 930
From 12 Mar 2025 to the primary completion date, 31 Oct 2033
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

1a. Type 1 diabetes or the presence of \>2 diabetes auto-antibodies (e.g., GAD-65, IA-2 antigen, Zinc transporter 8 autoantibodies).

Lab values

h. For Y-OW Participants- Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above.
- 2\. 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:
ALT or AST \>2 times the upper limit of normal
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.
- 3\. Biological Parents
- -No Exclusion Criteria

Age

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.

Other

An individual who meets any of the following criteria for their specific group will be excluded from participation in this study:
1\. Y-T2DM, Y-OW and Y-Lean Participants:
Glycosuria

Criteria the registry did not label

INCLUSION CRITERIA:
- To be eligible to participate in this study, an individual must meet the following criteria according to their group:
- Four categories of participants will be included in this study and the inclusion criteria for each group are given below:
Participants with Y-T2DM
- 1a.Age 12-25 years
- 1b.Type 2 diabetes mellitus as defined by fasting blood glucose \>= 126 mg/dL OR postprandial blood sugar \>= 200 mg/dL OR Hemoglobin A1c \>= 6.5% per American Diabetes Association Criteria and one element from the medical history consistent with ADA or AAP guidelines including: family history of diabetes and obesity, maternal or personal history of gestational diabetes, high-risk race and ethnicity, history of cardiovascular disease, hypertension, dyslipidemia, polycystic ovary syndrome, physical inactivity, other clinical conditions associated with insulin resistance (e.g. severe obesity, acanthosis nigricans, prediabetes), small or large for gestational age birth weight, history of breastfeeding, gestational history of illicit drugs including alcohol, smoking OR documentation of type 2 diabetes diagnosed at \<=25 years of age with verified medical history (as above).
- 2\. Youth with overweight/ obesity (Y-OW)
- 2a. Age 12-25 years
- 2b. For participants \< 18 years of age, BMI \>= 85th percentile (overweight) and \>= 95th percentile (obesity) for age and sex OR
- 2c. For participants \>= 18 years of age, BMI \>=25\<30 kg/m\^2 (overweight) or \>=30 kg/m\^2 (obesity)
- 2d. Participants with obesity may have a diagnosis of prediabetes, defined as fasting blood glucose 100-125 mg/dL OR postprandial blood sugar 140-199 mg/dL OR HbA1c 5.7-6.4 percent (either during testing at NIH or as previously documented on outside medical record).
- 3\. Healthy control lean participants (Y-Lean)
- 3a. Age 12-25 years
- 3b. For participants \< 18 years of age, BMI \<= 85th percentile for age and sex OR
- 3c. For participants \>=18 years of age, BMI 18-24.99 kg/m\^2.
- 3d. HbA1c \<5.7 percent (either during testing at NIH or as previously documented on outside medical record).
- 4\. Biological parents of Y-T2DM, Y-OW and Y-Lean participants
- 4a. Biological parent of enrolled Y-T2DM, Y-OW and Y-Lean by self-report.

Age in the registry: 12 years to 25 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Recruiting
Children's National Hospital (CNH) Coordinator of this site? Confirm its status	Washington D.C.	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.