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Phenotyping Genetic Risk for Type 2 Diabetes

Purpose

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.

Conditions

Diabetes Mellitus, Type 2
Genetics

Eligibility

Eligible Ages: Between 10 Years and 70 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

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 Design

Phase: N/A
Study Type: Interventional
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.

Arm Groups

Arm	Description	Assigned Intervention
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.

Recruiting Locations

University of Pennsylvania
Philadelphia, Pennsylvania 19104

Contact:
Jessica R Wilson, MD, MS
215 898-3389
jessica.wilson3@uphs.upenn.edu

More Details

NCT ID: NCT04024631
Status: Recruiting
Sponsor: University of Pennsylvania

Study Contact

Jessica R Wilson, MD, MS
215 898-3389
jessica.wilson3@uphs.upenn.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.