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Clinical Trials/NCT04024631
NCT04024631
Recruiting
Not Applicable

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

University of Pennsylvania2 sites in 1 country100 target enrollmentJune 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
University of Pennsylvania
Enrollment
100
Locations
2
Primary Endpoint
Glucose response to an oral glucose load
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 17, 2019
End Date
June 30, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica R.Wilson, MD, MS

Instructor in Medicine

University of Pennsylvania

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
  • 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

Outcomes

Primary Outcomes

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

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

Study Sites (2)

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