Diabetes Mellitus, Type 2, Genetics
Conditions
Keywords
polygenic risk for type 2 diabetes
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.
Interventions
OTHER75g 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.
OTHERDXA, whole body
Subjects will undergo a whole body DXA scan for assessment of adiposity index and body fat distribution.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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.
Intervention model description
cross sectional
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose response to an oral glucose load | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | DXA whole body scan visceral adiposity index |
| HOMA-IR | calculated from baseline fasting insulin and glucose levels | Insulin resistance estimate |
| Disposition index | samples will be collected over four hours after the 75g glucose beverage and these results will be used for mixed modeling | product of insulin sensitivity and amount of insulin released; calculated using mixed modeling techniques |
Countries
United States
Contacts
Primary ContactJessica R Wilson, MD, MS
Backup ContactEsther Oyerinde
Outcome results
None listed