Insulin SensitivityNCT03043235
Race Adiposity Interactions Regulate Mechanisms Determining Insulin Sensitivity
An observational study of Insulin Sensitivity and Fat; Liver, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Fat; Liver
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2014to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: African American and Caucasian Males and Females between 19-45 years old
Who may be able to join
- 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
Who cannot join
- Diabetes
- Any major medical conditions or medications that interfere with study outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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).
Read the detailed description
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
- Insulin Sensitivity, Fat; Liver
- Medical subject headings
- Insulin Resistance, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| African American Females | No intervention | |
| African American Males | No intervention | |
| Caucasian Females | No intervention | |
| Caucasian Males | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperinsulinemic isoglycemic glucose clamp
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start8 Jan 2014
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Gower, University of Alabama at Birmingham
- Investigators
- Barbara Gower, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043235
- Sponsor's protocol ID
- 2237
- Status last verified
- Jul 2018
- First submitted
- 2 Feb 2017
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34605220
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Race Adiposity Interactions Regulate Mechanisms Determining Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT03043235
- Acronym / sponsor ID
- 2237
- Conditions
- Insulin Sensitivity, Fat; Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 8 Jan 2014 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| African American Females | – | –No intervention |
| African American Males | – | –No intervention |
| Caucasian Females | – | –No intervention |
| Caucasian Males | – | –No intervention |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- African American and Caucasian Males and Females between 19-45 years old
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Diabetes
- Any major medical conditions or medications that interfere with study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hyperinsulinemic isoglycemic glucose clamp
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Derived from this study: PubMed 34605220Fisher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Gower, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Sensitivity and Fat; Liver, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperinsulinemic isoglycemic glucose clamp (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03043235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.