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Evaluatie van het klinische spectrum van diabetes en obesitas bij jongeren en volwassenen

6 november 2026 bijgewerkt door: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

1000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

8 jaar tot 65 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: OTHER
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To collect data and samples during clinical evaluation, treatment, and follow-up of participants for use in future studies.
Tijdsspanne: Up to 30 years

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
Up to 30 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Onderzoekers

  • Hoofdonderzoeker: Noemi Malandrino, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

12 november 2026

Primaire voltooiing (Geschat)

30 november 2054

Studie voltooiing (Geschat)

30 april 2055

Studieregistratiedata

Eerst ingediend

4 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 februari 2026

Eerst geplaatst (Werkelijk)

5 februari 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

8 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 10002229
  • 002229-DK

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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