Race Adiposity Interactions Regulate Mechanisms Determining Insulin Sensitivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-08

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Factors Involved in Obesity-related Inflammation and Insulin Resistance

NCT01173705

Obesity Insulin Resistance Inflammation

TERMINATED

Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes

NCT00726778

Healthy

COMPLETED

Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction

NCT03499509

Diet Modification

COMPLETED NA

Relationship Between Systemic Fatty Acid Availability and Insulin Sensitivity

NCT01452048

Obesity

COMPLETED

Effects of Macronutrients on Hepatic Lipids, Plasma Triglycerides, and Insulin Sensitivity

NCT00523562

Metabolic Syndrome X Liver Diseases

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Insulin resistance plays a major role in the etiology of chronic metabolic diseases, many of which differ with race/ethnicity. Previous studies using mainly indirect methods suggest that insulin sensitivity is lower in AA vs. EA. Our preliminary data using the reference standard glucose clamp indicate that in lean individuals, insulin sensitivity is lower among AA, while in obese individuals, insulin sensitivity is higher among AA. We hypothesize that this race/body mass index (BMI) interaction may be explained in part by significantly lower visceral and hepatic fat accumulation in AA. Conversely, based on our preliminary data, we hypothesize that inherently greater oxidative stress impairs insulin sensitivity even in AA, explaining lower insulin sensitivity in lean AA vs. EA. We propose to test these hypotheses by prospectively comparing skeletal muscle and hepatic insulin sensitivity in healthy lean, overweight, and obese AA and EA using the hyperinsulinemic isoglycemic glucose clamp. Analysis of ancestral genes will permit simultaneous assessment of the contribution of ancestry to main outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Sensitivity Fat; Liver

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

African American Females

No intervention

No interventions assigned to this group

African American Males

No intervention

No interventions assigned to this group

Caucasian Females

No intervention

No interventions assigned to this group

Caucasian Males

No intervention

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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