search
Back to results

Phenotyping Genetic Risk for Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2, Genetics

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
75g glucose beverage (Glucola, Trutol, or similar brand)
DXA, whole body
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring polygenic risk for type 2 diabetes

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Childrens Hospital of Philadelphia
  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Phenotyping

Arm 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.

Outcomes

Primary Outcome Measures

Glucose response to an oral glucose load
Glucose area under the curve after the 75g glucose beverage

Secondary Outcome Measures

Visceral adiposity index
DXA whole body scan visceral adiposity index
HOMA-IR
Insulin resistance estimate
Disposition index
product of insulin sensitivity and amount of insulin released; calculated using mixed modeling techniques

Full Information

First Posted
July 13, 2019
Last Updated
March 3, 2023
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT04024631
Brief Title
Phenotyping Genetic Risk for Type 2 Diabetes
Official Title
Phenotyping Children and Adults With Possible High or Low Genetic Risk for Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Genetics
Keywords
polygenic risk for type 2 diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
cross sectional
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.
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phenotyping
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
75g glucose beverage (Glucola, Trutol, or similar brand)
Intervention Description
Subjects will present fasting to the study day and ingest the glucose beverage during the oral glucose tolerance test.
Intervention Type
Other
Intervention Name(s)
DXA, whole body
Intervention Description
Subjects will undergo a whole body DXA scan for assessment of adiposity index and body fat distribution.
Primary Outcome Measure Information:
Title
Glucose response to an oral glucose load
Description
Glucose area under the curve after the 75g glucose beverage
Time Frame
samples will be collected over four hours and these results will be used to calculate area under the curve
Secondary Outcome Measure Information:
Title
Visceral adiposity index
Description
DXA whole body scan 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
Title
HOMA-IR
Description
Insulin resistance estimate
Time Frame
calculated from baseline fasting insulin and glucose levels
Title
Disposition index
Description
product of insulin sensitivity and amount of insulin released; calculated using mixed modeling techniques
Time Frame
samples will be collected over four hours after the 75g glucose beverage and these results will be used for mixed modeling

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica R Wilson, MD, MS
Phone
215 898-3389
Email
jessica.wilson3@uphs.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Oyerinde
Email
esther.oyerinde@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica R Wilson, MD, MS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lorraine Levitt Katz, MD
Organizational Affiliation
Childrens Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica R Wilson, MD, MS
Phone
215-898-3389
Email
jessica.wilson3@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Esther Oyerinde
Email
esther.oyerinde@pennmedicine.upenn.edu
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica R Wilson, MD, MS
Phone
215-898-3389
Email
jessica.wilson3@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Esther Oyerinde
Email
esther.oyerinde@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phenotyping Genetic Risk for Type 2 Diabetes

We'll reach out to this number within 24 hrs