NCT03043235

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

4.5 years

First QC Date

February 2, 2017

Last Update Submit

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

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

Biospecimen

Retention: SAMPLES WITH DNA

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

Insulin ResistanceFatty Liver

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLiver DiseasesDigestive System Diseases

Study Officials

  • Barbara Gower, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

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

Locations