Recruiting

Genetic Testing

Sponsor:

University of Pennsylvania

Code:

NCT04024631

Conditions

Diabetes Mellitus, Type 2

Genetics

Eligibility Criteria

Sex: All

Age: 10 - 70

Healthy Volunteers: Accepted

Interventions

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

DXA, whole body

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus, Type 2

Genetics

Study ID

NCT04024631

Start date

Jun 17, 2019

Status verified date

Aug, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Phenotyping

All participants will undergo a four-hour frequently sampled oral glucose tolerance test in which they will ingest a 75g glucose beverage (intervention) within five minutes and have samples collected at baseline and for four hours after.

They will also undergo a whole body DXA (intervention) during the study day.

Interventions

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

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

DXA, whole body

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jessica R Wilson, MD, MS

215 898-3389jessica.wilson3@uphs.upenn.edu

Esther Oyerinde

esther.oyerinde@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jessica R Wilson, MD, MS

215 898-3389jessica.wilson3@uphs.upenn.edu

Esther Oyerinde

esther.oyerinde@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 10, 2025

Last verified

Aug, 2025

Keywords

  • polygenic risk for type 2 diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-09-10.