RECRUITING

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

Talk to us

Conditions

ObesityType 2 DiabetesCardiovascular DiseaseOverweightYouth Onset Type 2 DiabetesLean

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. ...

Official Title

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

Quick Facts

Study Start:2025-03-12
Study Completion:2033-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06730113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with Y-T2DM
  2. * Age 12-25 years
  3. * 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 percent per American Diabetes Association Criteria OR documentation of type 2 diabetes diagnosed at \<=25 years of age
  4. * Youth with overweight/ obesity (Y-OW)
  5. * Age 12-25 years
  6. * For participants \< 18 years of age, BMI \>= 85th percentile (overweight) and \>= 95th percentile (obesity) for age and sex OR
  7. * For participants \>= 18 years of age, BMI \>=25\<30 kg/m\^2 (overweight) or \>=30 kg/m\^2 (obesity)
  8. * 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).
  9. * Healthy control lean participants (Y-Lean)
  10. * Age 12-25 years
  11. * For participants \< 18 years of age, BMI \<= 85th percentile for age and sex OR
  12. * For participants \>=18 years of age, BMI 18-24.99 kg/m\^2.
  13. * HbA1c \<5.7 percent (either during testing at NIH or as previously documented on outside medical record).
  14. * Biological parents of Y-T2DM, Y-OW and Y-Lean participants
  15. * Biological parent of enrolled Y-T2DM, Y-OW and Y-Lean by self-report.
  1. * Y-T2DM, Y-OW and Y-Lean Participants:
  2. * Type 1 diabetes or the presence of \>2 diabetes auto-antibodies (e.g., GAD-65, IA-2 antigen, Zinc transporter 8 autoantibodies).
  3. * 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).
  4. * 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).
  5. * For participants enrolled at the NIH, dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.
  6. * Unwilling to comply with all study procedures or to adhere to Lifestyle Considerations throughout study duration.
  7. * Pregnancy at the time of the screening visit.
  8. * Clinically significant anemia OR Hematocrit below the lower limit of normal for age and sex cutoffs.
  9. * Y-Lean participants:
  10. * 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.
  11. * Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g., niacin, fish oil, red yeast rice)
  12. * History of diabetes or abnormal glucose tolerance
  13. * Abnormal screening labs, including the following:
  14. * ALT or AST \>2 times the upper limit of normal
  15. * Glycosuria
  16. * 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
  17. * Biological Parents
  18. * No Exclusion Criteria

Contacts and Locations

Study Contact

Lilian S Mabundo
CONTACT
(240) 383-9379
lilian.mabundo@nih.gov
Stephanie T Chung, M.D.
CONTACT
(240) 479-8137
stephanie.chung@nih.gov

Principal Investigator

Stephanie T Chung, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

Children's National Hospital (CNH)
Washington, District of Columbia, 20010
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

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

  • Stephanie T Chung, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-12
Study Completion Date2033-10-31

Study Record Updates

Study Start Date2025-03-12
Study Completion Date2033-10-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Obesity
  • Type 2 Diabetes