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

NCT06730113 | Recruiting

• 2 other identifiers: 10001819001819-DK
• Study Type: observational
• Target: 930
• Locations: 1 country
• Sites: 2

Brief 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. 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

Obesity; Type 2 Diabetes

Keywords

Cardiovascular Disease; Overweight; Obesity; Youth Onset Type 2 Diabetes; Lean

Outcome Measures

Primary Outcomes (4)

• Pulse wave velocity (PWV)

  Carotid-femoral pulse wave velocity (m/s) measured with SphygmaCor, higher numbers indicated greater arterial stiffness

  Baseline

• Augmentation index (Aix)

  Augmentation index (%) measured with SphygmaCor, higher numbers indicated greater arterial stiffness.

  Baseline

• Pulse wave velocity (PWV)

  Carotid-femoral pulse wave velocity (m/s) measured with SphygmaCor

  5 Years

• Augmentation index (Aix)

  Augmentation index (%) measured with SphygmaCor

  5 Years

Secondary Outcomes (6)

• Right coronary wall thickness

  Baseline

• Right coronary wall thickness

  5 years

• Endothelial Function

  Baseline

• Endothelial Function

  5 years

• Fasting remnant lipoproteins

  Baseline

Study Arms (3)

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).

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• To be eligible to participate in this study, an individual must meet the following criteria according to their group:
• Participants with Y-T2DM
• a.Age 12-25 years
• b.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).
• \. Youth with overweight/ obesity (Y-OW)
• a. Age 12-25 years
• b. For participants \< 18 years of age, BMI \>= 85th percentile (overweight) and \>= 95th percentile (obesity) for age and sex OR
• c. For participants \>= 18 years of age, BMI \>=25\<30 kg/m\^2 (overweight) or \>=30 kg/m\^2 (obesity)
• d. 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).
• \. Healthy control lean participants (Y-Lean)
• a. Age 12-25 years
• b. For participants \< 18 years of age, BMI \<= 85th percentile for age and sex OR
• c. For participants \>=18 years of age, BMI 18-24.99 kg/m\^2.
• d. HbA1c \<5.7 percent (either during testing at NIH or as previously documented on outside medical record).
• \. Biological parents of Y-T2DM, Y-OW and Y-Lean participants

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:
• a. 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).
• c. 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).
• d. For participants enrolled at the NIH, dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.
• e. Unwilling to comply with all study procedures or to adhere to Lifestyle Considerations throughout study duration.
• f. Pregnancy at the time of the screening visit.
• g. Clinically significant anemia OR Hematocrit below the lower limit of normal for age and sex cutoffs.
• \. Y-Lean participants:
• a. 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.
• b. Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g., niacin, fish oil, red yeast rice)
• c. History of diabetes or abnormal glucose tolerance
• d.. Abnormal screening labs, including the following:
• i) ALT or AST \>2 times the upper limit of normal

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (2)

Children's National Hospital (CNH)

Washington D.C., District of Columbia, 20010, United States

RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephanie T Chung, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilian S Mabundo

CONTACT

(240) 383-9379; lilian.mabundo@nih.gov

Stephanie T Chung, M.D.

CONTACT

(240) 479-8137; stephanie.chung@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 12, 2024
• Study Start: March 12, 2025
• Primary Completion (Estimated): October 31, 2033
• Study Completion (Estimated): October 31, 2033
• Last Updated: April 15, 2026

Record last verified: 2026-04-13

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be provided upon request within 1 year after publication and will be available for at least 10 years
• Access Criteria: The PI will accept requests from other researchers who are examining pertinent outcomes.

Locations

US (2)