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NCT04024631 | RECRUITING | Diabetes Mellitus, Type 2

Phenotyping Genetic Risk for Type 2 Diabetes
Sponsor:

University of Pennsylvania

Information provided by (Responsible Party):

Jessica R.Wilson, MD, MS

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.

Condition or disease

Diabetes Mellitus, Type 2

Genetics

Intervention/treatment

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

DXA, whole body

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
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.
Primary Purpose : OTHER
Official Title : Phenotyping Children and Adults With Possible High or Low Genetic Risk for Type 2 Diabetes
Actual Study Start Date : 2019-06-17
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 10 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Phenotyping Genetic Risk for Type 2 Diabetes

Location Details

NCT04024631

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Pennsylvania

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104