Phenotyping Genetic Risk for Type 2 Diabetes

NCT ID: NCT04024631

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Genetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

cross sectional
Primary Study Purpose

OTHER

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type OTHER

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

Intervention Type OTHER

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

DXA, whole body

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

DXA, whole body

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Jessica R.Wilson, MD, MS

Instructor in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica R Wilson, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Lorraine Levitt Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica R Wilson, MD, MS

Role: CONTACT

215 898-3389

Esther Oyerinde

Role: CONTACT

Facility Contacts

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Jessica R Wilson, MD, MS

Role: primary

215 898-3389

Esther Oyerinde

Role: backup

Jessica R Wilson, MD, MS

Role: primary

215 898-3389

Esther Oyerinde

Role: backup

Other Identifiers

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831865

Identifier Type: -

Identifier Source: org_study_id

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