Phenotyping Genetic Risk for Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04024631
• Other study ID #: 831865
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: University of Pennsylvania
• Contact: Jessica R Wilson, MD, MS
• Phone: 215 898-3389
• Email: jessica.wilson3[@]uphs.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Genetics

Intervention

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

Locations

Country	Name	City	State
United States	Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	HOMA-IR	Insulin resistance estimate	calculated from baseline fasting insulin and glucose levels
Secondary	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