Phenotyping Genetic Risk for Type 2 Diabetes

NCT04024631 | Recruiting

• 1 other identifier: 831865
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Keywords

polygenic risk for type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Glucose response to an oral glucose load

  Glucose area under the curve after the 75g glucose beverage

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

Secondary Outcomes (3)

• Visceral adiposity index

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

• HOMA-IR

  calculated from baseline fasting insulin and glucose levels

• Disposition index

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

Study Arms (1)

Phenotyping

OTHER

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.

Other: 75g glucose beverage (Glucola, Trutol, or similar brand); Other: DXA, whole body

Interventions

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.

Phenotyping

DXA, whole body OTHER

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

Phenotyping

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucola; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jessica R Wilson, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Lorraine Levitt Katz, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica R Wilson, MD, MS

CONTACT

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

Esther Oyerinde

CONTACT

esther.oyerinde@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Data analyses (including by outcomes assessors and investigators) will be de-identified, and individuals performing laboratory analyses and DXA interpretation will be blinded to polygenic risk score for type 2 diabetes. Participants and nursing staff will not be informed of polygenic risk score at the time of the study.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Model Details: cross sectional

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 18, 2019
• Study Start: June 17, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)