Race Adiposity Interactions Regulate Mechanisms Determining Insulin Sensitivity
1 other identifier
observational
126
1 country
1
Brief Summary
This research study will examine how ethnic/racial background, body composition (%body fat), and the location of body fat affect the ability of the hormone insulin to promote uptake of blood sugar in persons who are 19 to 45 years of age. When insulin is ineffective in promoting blood sugar uptake, this condition is termed "insulin resistance." Insulin resistance plays a major role in the development of chronic metabolic diseases (such as type 2 diabetes, cardiovascular disease, and cancer), many of which differ with race. Previous studies suggest that insulin resistance is higher in African-Americans (AA) vs. European-Americans (EA). However, results from these studies remain unclear due to different testing measures used for insulin resistance as well as differences in body fat between individuals. Results from this research study may help explain why insulin resistance differs with genetic background and may guide development of personalized treatment strategies with implications for several chronic metabolic diseases (e.g., type 2 diabetes, cardiovascular disease, and cancer).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2014
CompletedFirst Submitted
Initial submission to the registry
February 2, 2017
CompletedFirst Posted
Study publicly available on registry
February 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedJuly 16, 2018
July 1, 2018
4.5 years
February 2, 2017
July 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Hyperinsulinemic isoglycemic glucose clamp
5 years
Study Arms (4)
African American Females
No intervention
African American Males
No intervention
Caucasian Females
No intervention
Caucasian Males
No intervention
Eligibility Criteria
African American and Caucasian Males and Females between 19-45 years old
You may qualify if:
- African American or Caucasian
- Body Mass Index 19-45
- Do NOT have diabetes
- Exercise less than 2 hours per week
- Are willing to travel to UAB for 2 screens and 4 testing visits
You may not qualify if:
- Diabetes
- Any major medical conditions or medications that interfere with study outcomes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Related Publications (1)
Fisher G, Tay J, Warren JL, Garvey WT, Yarar-Fisher C, Gower BA. Sex and race contribute to variation in mitochondrial function and insulin sensitivity. Physiol Rep. 2021 Oct;9(19):e15049. doi: 10.14814/phy2.15049.
PMID: 34605220DERIVED
Biospecimen
DNA will be used to identify ancestry. This information is needed to understand why African Americans and Caucasians have different risks for developing certain diseases.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Gower, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal Investigator
Study Record Dates
First Submitted
February 2, 2017
First Posted
February 3, 2017
Study Start
January 8, 2014
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
July 16, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share