Phenotyping Genetic Risk for Type 2 Diabetes

University of Pennsylvania

Status: Enrolling

Conditions: Genetics; Diabetes Mellitus, Type 2

Treatments: Other: DXA, whole body; Other: 75g glucose beverage (Glucola, Trutol, or similar brand)

Study type: Interventional

Funder types: Other

Identifiers

NCT04024631

831865

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Phenotyping

Other group

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.

Treatment:

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

Other: DXA, whole body