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Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 30 years
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Questionnaires will ask about participant s eating habits, feelings, sleep, and substance use."
  • "Care providers will address any issues revealed in these surveys."
  • "Participants may remain in the study up to 30 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how diabetes and obesity develop and change over time. It is for people ages 8 to 65 who are overweight, have obesity, or have signs of high blood sugar. Researchers will collect health information and samples during regular NIH clinic visits for up to 30 years.

Background: Diabetes and obesity are chronic diseases. They can affect blood flow and how the body processes nutrients, and complications over time can lead to early death. Diabetes can affect children as well as adults, but the disease seems to be more severe and to progress faster when it appears in younger people. Researchers want to understand more about how diabetes and obesity develop and change over time. Objective: To collect data and samples regularly from people with obesity and diabetes. Eligibility: People aged 8 to 65 years. They must be overweight or obese; or have high blood sugar; or have problems with how their body uses food for energy. Design: Participants will have additional procedures during routine care visits at the NIH clinic. Data collected for the study will include the following: Information from the participant s medical chart will be kept for research. Questionnaires will ask about participant s eating habits, feelings, sleep, and substance use. They will take 30 to 60 minutes. Care providers will address any issues revealed in these surveys. Blood, saliva, urine, and stool samples will be collected. Samples may be used for genetic tests. Data and samples will be kept for future research. Participants may remain in the study up to 30 years.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 8 to 65 years old and meet at least one of the weight or blood sugar conditions below.
  • Under age 18: Your BMI, a measure of weight compared with height, is at or above the 85th percentile for your age and sex.
  • Age 18 or older: Your BMI is at least 25, or at least 23 if you identify as Asian.
  • You have a diagnosis of prediabetes or diabetes in your health record or reported by you, your guardian, or your legal representative.
  • Your health record shows blood sugar of at least 100 mg/dL after fasting (not eating).
  • Your health record shows blood sugar of at least 140 mg/dL after eating.
  • Your health record shows an A1c of at least 5.7%. This test measures average blood sugar over time.

Who can't join

  • You have a serious illness that the study team thinks could interfere with study tests, such as a life-threatening illness or severe organ failure.
  • You have a medical, mental health, or social condition that the study team thinks would make joining the study not in your best interest.
  • You, your parent or guardian, or your legal representative cannot or will not give informed consent, which means agreeing to join after learning about the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Age 8 years to 65 years 2. Meet at least one of the following: a. Overweight/Obesity: i. For participants under 18 years of age: BMI \>= 85th percentile for age and sex ii. For participants \>= 18 years of age: BMI \>= 25 kg/m\^2 (\>=23 kg/m\^2 for self-reported Asian race/ethnicity) b. Suspected or evidence of hyperglycemia: i. Diagnosis of prediabetes or diabetes in medical history or by participant/guardian/Legally Authorized Representative (LAR) report, OR ii. Fasting blood glucose \>= 100 mg/dL in medical record, OR iii. Postprandial blood sugar \>= 140 mg/dL in medical record, OR iv. Hemoglobin A1c \>= 5.7% in medical record EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. History of significant medical illnesses that the investigators feel may interfere with potential evaluations, i.e. individuals who are critically ill, unstable, or with severe organ failure that may affect/limit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources. 2. History of any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the participant. 3. Inability or unwillingness of participant, parent/guardian, or LAR to provide informed consent.

Study sites (1)

MD