Phenotyping Genetic Risk for Type 2 Diabetes

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

Sponsors

Lead Sponsor: University of Pennsylvania

Source University of Pennsylvania
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.

Detailed Description

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.

Overall Status Recruiting
Start Date June 17, 2019
Completion Date June 30, 2023
Primary Completion Date June 30, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Glucose response to an oral glucose load samples will be collected over four hours and these results will be used to calculate area under the curve
Secondary Outcome
Measure Time Frame
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
Enrollment 100
Condition
Intervention

Intervention Type: Other

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

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

Arm Group Label: Phenotyping

Intervention Type: Other

Intervention Name: DXA, whole body

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

Arm Group Label: Phenotyping

Eligibility

Criteria:

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

Gender: All

Minimum Age: 10 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Overall Contact

Last Name: Jessica R Wilson, MD, MS

Phone: 215 898-3389

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup:
Childrens Hospital of Philadelphia | Philadelphia, Pennsylvania, 19104, United States Not yet recruiting Jessica R Wilson, MD, MS 215-898-3389 [email protected]
University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Recruiting Jessica R Wilson, MD, MS 215-898-3389 [email protected]
Location Countries

United States

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Pennsylvania

Investigator Full Name: Jessica R.Wilson, MD, MS

Investigator Title: Instructor in Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Phenotyping

Type: Other

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: cross sectional

Primary Purpose: Other

Masking: None (Open Label)

Masking Description: 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.

Source: ClinicalTrials.gov