Following people with diabetes and obesity over time through routine clinic visits
Collects health data and samples from people with diabetes or obesity over many years.
Key facts
- Who runs it
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Where
- Bethesda, United StatesSee the site
- Trial code
- Registry title
- Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
- Status
- Not yet recruiting
- People taking part
- 1,000 people, planned
- Starts
- 18 Nov 2026
- Expected to end
- 30 Apr 2055
- Type of study
- Observational, 2 groups
- Record updated
- 13 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 8 to 65 who are overweight or obese, or who have high blood sugar or a diagnosis of prediabetes or diabetes.
- Age
- 8 years to 65 years
- Sex
- All sexes can join.
- Disease stage
- Overweight or obesity (BMI at or above the 85th percentile for age and sex under 18; BMI 25 kg/m^2 or more from 18, or 23 kg/m^2 or more for self-reported Asian race or ethnicity), OR high blood sugar: prediabetes or diabetes in the history, fasting blood glucose 100 mg/dL (5.6 mmol/L) or more, blood sugar after a meal 140 mg/dL (7.8 mmol/L) or more, or hemoglobin A1c 5.7% (39 mmol/mol) or more.
Main reasons for not taking part
- Serious illness that the investigators think could interfere with the evaluations, such as being critically ill, unstable, or having severe organ failure
- Medical, psychiatric or social conditions that make joining not in the participant's interest, in the investigators' opinion
- Unable or unwilling to give informed consent (participant, parent, guardian or legally authorized representative)
The registry criteria, word for word
Show all 13 criteriaShow less
Who cannot take part
- 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
- 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
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability or unwillingness of participant, parent/guardian, or LAR to provide informed consent
Other criteria
- INCLUSION CRITERIA:; In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age 8 years to 65 years
- Meet at least one of the following:; Overweight/Obesity:; For participants under 18 years of age: BMI >= 85th percentile for age and sex
- For participants >= 18 years of age: BMI >= 25 kg/m\^2 (>=23 kg/m\^2 for self-reported Asian race/ethnicity)
- Suspected or evidence of hyperglycemia:
- Diagnosis of prediabetes or diabetes in medical history or by participant/guardian/Legally Authorized Representative (LAR) report, OR
- Fasting blood glucose >= 100 mg/dL in medical record, OR
- Postprandial blood sugar >= 140 mg/dL in medical record, OR
- Hemoglobin A1c >= 5.7% in medical record
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 65 years old?
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesContact: Noemi Malandrino, M.D.Not yet recruiting
About the trial
What the trial wants to find out
Background:
Read full original descriptionShow less
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.
The 2 groups in the trial
- Adults with suspected or established hyperglycemia, overweight or obesity, or metabolic disease
Data and samples will be obtained during complete comprehensive clinical screening procedures and provision of standard of care treatments. Data and samples to be retained may include either residual samples/ data not otherwise needed for clinical care or additional samples/ data collected during the course of clinical care. These data will provide information to prevent the development and/or progression of cardiovascular disease and other diabetes-related complications, to increase the understanding of these disease processes in patients with different age of onset of metabolic disease, and how available treatments affect the prognosis in these patients.
- Youth with suspected or established hyperglycemia, overweight or obesity, or metabolic disease
Data and samples will be obtained during complete comprehensive clinical screening procedures and provision of standard of care treatments. Data and samples to be retained may include either residual samples/ data not otherwise needed for clinical care or additional samples/ data collected during the course of clinical care. These data will provide information to prevent the development and/or progression of cardiovascular disease and other diabetes-related complications, to increase the understanding of these disease processes in patients with different age of onset of metabolic disease, and how available treatments affect the prognosis in these patients.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
- Plain-language title
- Following people with diabetes and obesity over time through routine clinic visitsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07388537, who can take part
- Record updated
- 13 November 2026