Young hearts at risk: 25-Year study launches to uncover Diabetes-Heart link
NCT ID NCT06730113
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 7 times
Summary
This study aims to learn how type 2 diabetes and obesity in young people affect heart and blood vessel health over time. About 930 participants aged 12 to 25, including those with diabetes, overweight but not diabetic, and healthy lean individuals, will be followed for up to 25 years. They will have yearly check-ups including heart tests, scans, and blood sugar monitoring. No treatments are given; the goal is to gather information to better understand and prevent heart disease in this group.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 930 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Oct 2033
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will evaluate the pathophysiological features of cardiovascular disease in youth-onset type 2 diabetes (Y-T2DM) using a multi-level, multi-domain approach of socio-ecological risk factors (societal, community, and individual). We will employ a prospective, observational study design in youth aged 12-25 years to compare Y-T2DM with age and BMI-matched youth with overweight or obesity (Y-OW) and age-matched healthy lean peers (Y-Lean). The study will also include a single-day visit for biological parents of enrolled Y-T2DM, Y-OW and Y- lean, to assess parental factors involved in the pathophysiology of cardiovascular disease in Y-T2DM.
- Ages
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12 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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: 1. 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. EXCLUSION CRITERIA: 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: 1a. Type 1 diabetes or the presence of \>2 diabetes auto-antibodies (e.g., GAD-65, IA-2 antigen, Zinc transporter 8 autoantibodies). 1. 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. 1. 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: 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. 3\. Biological Parents -No Exclusion Criteria
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's National Hospital (CNH)
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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