Phenotyping Genetic Risk for Type 2 Diabetes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Genetics
• Intervention / Treatment: Other: 75g glucose beverage (Glucola, Trutol, or similar brand); Other: DXA, whole body

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • Childrens Hospital Of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.; Other: DXA, whole body; Subjects will undergo a whole body DXA scan for assessment of adiposity index and body fat distribution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visceral adiposity index	DXA whole body scan 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	Insulin resistance estimate	calculated from baseline fasting insulin and glucose levels
Disposition index	product of insulin sensitivity and amount of insulin released; calculated using mixed modeling techniques	samples will be collected over four hours after the 75g glucose beverage and these results will be used for mixed modeling

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: July 13, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: polygenic risk for type 2 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 831865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No