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

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Dec 11, 2024

Keywords

ClinConnect Summary

The Young at Heart Prospective Cohort Study is looking at how obesity and type 2 diabetes in young people can lead to heart and blood vessel diseases. This is important because the number of young people with type 2 diabetes has increased dramatically over the last few decades. The study aims to understand how these conditions affect heart health in kids and young adults aged 12 to 25.

To participate, individuals need to meet certain criteria: they can either have type 2 diabetes, be overweight, or be healthy and lean. Participants will visit the NIH clinic once a year for up to 25 years, where they will undergo various tests, like providing blood samples and exercising on a stationary bike. They will also wear devices to monitor their activity and blood sugar levels outside of the clinic. Biological parents of the participants will also be included in the study with a separate visit for health assessments. This research is crucial in helping to identify factors that could prevent heart disease in young people with diabetes and obesity.

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Eligibility criteria

• * 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 Criteria