An observational study in Obesity, Diabetes and Metabolic Disorders, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Not yet recruiting at 1 site in United States. Open to participants aged 8 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational
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.
Study Description:
This is a single-site observational study conducted at the NIH Clinical Center. Youth and adults who have suspected or established hyperglycemia, overweight or obesity, or metabolic disease, or who require clinical screening for such conditions are provided standard clinical care. Data and samples obtained during regular clinical care will be retained for future research. Recommendations for other treatment options outside of the NIH will be discussed with study participants and may be discussed with their primary or referring physicians.
The schedule a participant follows will be based on their unique clinical needs.
Objectives:
To collect data and samples during clinical evaluation, treatment, and follow-up of participants for use in future studies.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
This is a single-site observational study conducted at the NIH Clinical Center. Youth and adults who have suspected or established hyperglycemia, overweight or obesity, or metabolic disease, or who require clinical screening for such conditions are provided standard clinical care. Data and samples obtained during regular clinical care will be retained for future research. Recommendations for other treatment options outside of the NIH will be discussed with study participants and may be discussed with their primary or referring physicians. The schedule a participant follows will be based on their unique clinical needs.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Meet at least one of the following:
a. Overweight/Obesity:
i. For participants under 18 years of age: >= 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. >= 5.7% in medical record
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
To collect data and samples during clinical evaluation, treatment, and follow-up of participants for use in future studies.
Samples including whole blood, saliva/buccal swabs, urine, and/or stool will be collected and stored for use in future studies to test our hypothesis that individuals with youth and adult early-onset diabetes and obesity will have high rates of metabolic complications and rapid disease progression compared to adults who develop diabetes later in their life. These samples will be collected during the participants' clinical care visits
Time frame: Up to 30 years
Plan to share: Yes — For associate protocols, identifiable data will be de-identified prior to repository submission. Participant level clinical data related to primary outcomes, will be preserved through deposition of the data in a controlled access public repository.
Supporting information: Study protocol
Time frame: Scientific data will be shared as soon as possible. Scientific data included in published manuscript will be available at the time of publication. All other generated data will be shared no later than at the end of the award.
Access criteria: The study protocol, data dictionary and a glossary of domain-specific terms to facilitate interpretation of scientific data related to primary outcomes will be submitted.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) →