ObesityNCT06730113
Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study
An observational study of Obesity and Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- How many people
- 930 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2025to 31 Oct 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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).
- 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.
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- 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.
- 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
- Glycosuria
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Stephanie Chung, M.D., 240-479-8137, stephanie.chung@nih.gov
- Recruiting
Children's National Hospital (CNH)
Washington D.C., District of Columbia, 20010
Doris Estrada, 202-476-2121, destrada@childrensnational.org
About this study
Official title: Youth-onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study
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.
Read more
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.
...
Read the detailed description
Study Description:
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.
Objectives:
Primary Objectives:
- To compare pulse wave velocity (PWV) at baseline in Y-T2DM vs Y-OW and age-matched peers Y-Lean.
- To compare augmentation index (Aix) at baseline in Y-T2DM vs Y-OW and age-matched peers Y-Lean.
- To compare pulse wave velocity (PWV) at 5 years in Y-T2DM vs Y-OW and age-matched peers Y-Lean.
- To compare augmentation index (Aix) at 5 years in Y-T2DM vs Y-OW and age-matched peers Y-Lean.
Secondary Objectives:
In Y-T2DM vs. Y-OW vs. Y-Lean youth,
- To evaluate coronary artery structure and endothelial function at baseline and 5 years.
- To evaluate the relationship of pulse wave velocity and coronary artery structure \& endothelial function with atherogenic and remnant lipoproteins.
Exploratory Objectives:
In Y-T2DM vs. Y-OW vs. Y-Lean youth,
- To evaluate annual change in vascular aging (measured by the change in pulse wave velocity and endothelial function).
- To evaluate the relationship of physiologic, psychological stress (measured with the allostatic load score, ALS), psychosocial and behavioral factors with vascular aging.
- To evaluate biomarkers for vascular aging; ex. Beta-cell function, insulin resistance, inflammatory markers, and novel lipid parameters.
- To evaluate the association of polygenic risk scores (PRS) in Y-T2DM and with changes in glucose and metabolic profiles (e.g., triglycerides) over time.
- To evaluate differences in epigenetic aging in youth and parents.
- To determine the prevalence rates of major adverse cardiovascular events (MACE)
Endpoints:
Primary Endpoint:
- Carotid-femoral pulse wave velocity (PWV) at baseline
- Pulse augmentation index (Aix) at baseline
- Carotid-femoral PWV at 5 years
- Pulse Aix at 5 years
Secondary Endpoints:
- Right coronary wall thickness measured by cardiac MRI
- Endothelial function measured by MRI isometric handgrip exercise
- Fasting and postprandial lipoprotein profile (mixed meal test)
Exploratory Endpoints:
Markers of vascular aging (annual change):
- PWV
- Aix
- Endothelial function measured by reactive hyperemia index
- Right coronary wall thickness measured by MRI
- Heart rate variability
- Central Retinal Artery Equivalent
Markers of physiological stress
- Allostatic load score
- Cortisol (serum)
- C-reactive protein and immune biomarkers
Assessment of metabolic variables
- Sigma and insulin sensitivity index (standard 75g OGTT)
- Postprandial lipoproteins (mixed meal test)
- Metabolomics, Lipidomics, Proteomics Measures
- Liver fat and function
- Body composition
Psychosocial, Neighborhood, and individual variables
- Psychosocial Assessments: Binge Eating Disorder Screener-7 (BED-7), Brief Resilience Scale, Diabetes Distress Scale (DDS-17), Emotional Eating Scale, Michigan Neuropathy Screening Instrument (MNSI), PROMIS Emotional Distress - Anxiety, PROMIS Emotional Distress - Depression, PROMIS - Sleep Disturbance, Reward-Based Eating Drive Scale (REDS), Self-assessment of Worries, Concerns, and Burdens Related to Diabetes and Preparation for Transitioning, Substance Use, and Stroop Color and Word Test
- Neighborhood Assessments: Adverse Childhood Experience (ACE), Confusion, Hubbub, and Order Scale (CHAOS), MacArthur Scale of Subjective Social Status, Neighborhood Disadvantage Scale, Pediatric ACES and Related Life Events Screening (PEARLS), Unpredictability Beliefs Scale, and U.S. Household Food Insecurity Module.
- Individual Assessments: dietary, activity, sleep assessment questionnaire, stress-related eating, 7-10-day accelerometer (activity, sleep), 7-10-day continuous glucose monitor
Genetic/ Epigenetic
- Genome-wide genotyping array
- Genome-wide DNA methylation array
Five-point MACE
- Acute myocardial infarction
- Stroke
- Cardiovascular mortality
- Hospitalization for unstable angina or revascularization procedures
- Heart failure
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Cardiovascular Disease, Overweight, Obesity, Youth Onset Type 2 Diabetes, Lean
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control lean participants (Y-Lean) | 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). | |
| Y-T2DM | 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). | |
| Youth with overweight/ obesity (Y-OW | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity (PWV)
Carotid-femoral pulse wave velocity (m/s) measured with SphygmaCor, higher numbers indicated greater arterial stiffness
Measured: Baseline
Augmentation index (Aix)
Augmentation index (%) measured with SphygmaCor, higher numbers indicated greater arterial stiffness.
Measured: Baseline
Pulse wave velocity (PWV)
Carotid-femoral pulse wave velocity (m/s) measured with SphygmaCor
Measured: 5 Years
Augmentation index (Aix)
Augmentation index (%) measured with SphygmaCor
Measured: 5 Years
Secondary outcomes (6)
Right coronary wall thickness
During cardiac MRI, cross-sectional analysis of right coronary artery vessel wall thickness; greater thickness associated with increased risk for endothelial dysfunction
Measured: Baseline
Right coronary wall thickness
During cardiac MRI, cross-sectional analysis of right coronary artery vessel wall thickness; greater thickness associated with increased risk for endothelial dysfunction
Measured: 5 years
Endothelial Function
During cardiac MRI, measurements of change in vessel wall thickness during isometric handgrip exercise. Smaller change associated with endothelial dysfunction
Measured: Baseline
Endothelial Function
During cardiac MRI, measurements of change in vessel wall thickness during isometric handgrip exercise. Smaller change associated with endothelial dysfunction
Measured: 5 years
Fasting remnant lipoproteins
Fasting plasma remnant lipoproteins measured with nuclear magnetic spectroscopy; higher concentrations associated with increased cardiovascular disease risk
Measured: Baseline
Postprandial remnant lipoproteins
Plasma remnant lipoproteins measured with nuclear magnetic spectroscopy. Incremental area under the curve for plasma remnant lipoproteins will be calculated from the standard 5-hour mixed meal tolerance test.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start12 Mar 2025
- Primary completion31 Oct 2033 (estimated)
- Study completion31 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 930 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephanie T Chung, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730113
- Sponsor's protocol ID
- 10001819
- Other IDs
- 001819-DK
- Status last verified
- 15 Sep 2026
- First submitted
- 11 Dec 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will provide raw data (without identifying information) to journals or other researchers upon request.