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NCT Number: NCT04024631

Phenotyping Genetic Risk for Type 2 Diabetes

This study tests the hypothesis that non-diabetic individuals with a high genetic risk score for type 2 diabetes have impaired glucose tolerance and insulin resistance compared to those with a low genetic risk score for type 2 diabetes.

Recruiting

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Key information

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

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About this study

The study team will recruit individuals based on genetic risk score for type 2 diabetes from the biobank populations who have agreed to be recontacted for future research. Each participant will undergo a frequently sampled four-hour oral glucose tolerance test and whole body DXA scan (dual-energy X-ray absorptiometry) in addition to baseline laboratory and history assessment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 10-70 years
  • Prior participant of the UPenn Biobank or Center for Applied Genomics Biobank and agreed to be recontacted for future research.
  • Adults with BMI 25kg/m2 or higher, children and adolescents with BMI 85th percentile or higher

Exclusion criteria

  • prior diagnosis of type 1, type 2, or secondary diabetes
  • use of medications that would impact glucose and insulin response such as steroids, metformin or other anti-diabetic medication
  • acute illness that may impact insulin and glucose dynamics
  • pregnancy
  • hypothalamic obesity or related genetic disorder of metabolism
  • recent systemic chemotherapy use
  • gastrointestinal impairment or surgery that may impact absorption
  • anemia
  • major organ system illness or any underlying condition requiring regular medication or treatment that could make implementation of the protocol or interpretation of the study results difficult
  • inability to comply with study protocol

Treatment and study plan

75g glucose beverage (Glucola, Trutol, or similar brand)

Other

Subjects will present fasting to the study day and ingest the glucose beverage during the oral glucose tolerance test.

DXA, whole body

Other

Subjects will undergo a whole body DXA scan for assessment of adiposity index and body fat distribution.

Primary outcomes

  1. Glucose response to an oral glucose load

    Time frame: samples will be collected over four hours and these results will be used to calculate area under the curve

    Glucose area under the curve after the 75g glucose beverage

Secondary outcomes

  1. Visceral adiposity index

    Time frame: DXA scan will be obtained on the same day as the oral glucose test and will be completed in less than 30 minutes

    DXA whole body scan visceral adiposity index

  2. HOMA-IR

    Time frame: calculated from baseline fasting insulin and glucose levels

    Insulin resistance estimate

  3. Disposition index

    Time frame: samples will be collected over four hours after the 75g glucose beverage and these results will be used for mixed modeling

    product of insulin sensitivity and amount of insulin released; calculated using mixed modeling techniques

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Oyerinde

CONTACT

[email protected]

Jessica R Wilson, MD, MS

CONTACT

[email protected]

215 898-3389

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Phenotyping Children and Adults With Possible High or Low Genetic Risk for Type 2 Diabetes

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2019
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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