Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study
NCT06730113
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. ...
Eligibility
* 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
* Age 12-25 years
* 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
* Youth with overweight/ obesity (Y-OW)
* Age 12-25 years
* For participants \< 18 years of age, BMI \>= 85th percentile (overweight) and \>= 95th percentile (obesity) for age and sex OR
* For participants \>= 18 years of age, BMI \>=25\<30 kg/m\^2 (overweight) or \>=30 kg/m\^2 (obesity)
* 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)
* Age 12-25 years
* For participants \< 18 years of age, BMI \<= 85th percentile for age and sex OR
* For participants \>=18 years of age, BMI 18-24.99 kg/m\^2.
* 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
* 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:
* Y-T2DM, Y-OW and Y-Lean Participants:
* Type 1 diabetes or the presence of \>2 diabetes auto-antibodies (e.g., GAD-65, IA-2 antigen, Zinc transporter 8 autoantibodies).
* 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).
* 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).
* For participants enrolled at the NIH, dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.
* Unwilling to comply with all study procedures or to adhere to Lifestyle Considerations throughout study duration.
* Pregnancy at the time of the screening visit.
* Clinically significant anemia OR Hematocrit below the lower limit of normal for age and sex cutoffs.
* 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:
* 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.
* Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g., niacin, fish oil, red yeast rice)
* History of diabetes or abnormal glucose tolerance
* 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
* Biological Parents
* No Exclusion CriteriaConditions4
Locations2 sites
District of Columbia
1 siteMaryland
1 siteBrowse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT06730113