Phenotyping Genetic Risk for Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 75g glucose beverage (Glucola, Trutol, or similar brand), DXA, whole body.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Genetics. Basic parameters: 10 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phenotyping Children and Adults With Possible High or Low Genetic Risk for Type 2 Diabetes
Overview
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
- 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.
Primary outcome measures
- Glucose response to an oral glucose load [Time frame: samples will be collected over four hours and these results will be used to calculate area under the curve]
Secondary outcome measures (3)
- Visceral adiposity index [Time frame: 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 [Time frame: calculated from baseline fasting insulin and glucose levels]
- Disposition index [Time frame: samples will be collected over four hours after the 75g glucose beverage and these results will be used for mixed modeling]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Childrens Hospital of Philadelphia — Philadelphia
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT04024631 · 831865