ObesityNCT07388537
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
An observational study of Obesity and Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 65 years
- Conditions the study is for
- Obesity, Diabetes, Metabolic Disorders
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 30 Apr 2055
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
- Inability or unwillingness of participant, parent/guardian, or LAR to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Noemi Malandrino, M.D., 301-402-4006, noemi.malandrino@nih.gov
Lilian Mabundo, (240) 383-9379, lilian.mabundo@nih.gov
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Obesity, Diabetes, Metabolic Disorders
- Keywords
- Clinical Spectrum of Diabetes, Obesity, Hyperglycemia, Metabolic Disease
- Medical subject headings
- Obesity, Diabetes Mellitus, Metabolic Diseases, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start28 Oct 2026 (estimated)
- Primary completion30 Nov 2054 (estimated)
- Study completion30 Apr 2055 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Noemi Malandrino, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388537
- Sponsor's protocol ID
- 10002229
- Other IDs
- 002229-DK
- Status last verified
- 8 May 2026
- First submitted
- 4 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.