- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01452048
Relationship Between Systemic Fatty Acid Availability and Insulin Sensitivity
March 18, 2022 updated by: Jeffrey F Horowitz, University of Michigan
The investigators specific aim is to compare the relationship between systemic fatty acid availability and insulin sensitivity in a relatively homogenous population of obese adults.
The investigators anticipate 1) greater systemic fatty acid availability will be associated with lower insulin sensitivity and 2) greater systemic fatty acid availability will be associated with greater accumulation of fatty acid intermediates and pro-inflammatory markers.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Michigan Clincal Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
UM Health System patients from Dr. Amy Rothberg and colleagues UM Investigational Weight Management Clinic (IWMC) Community Sample
Description
Inclusion Criteria:
- Body mass index [BMI]: 35-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)
Exclusion Criteria:
- Weight instability ≥ ±5 lbs. in past month; medications known to affect lipid and/or glucose metabolism; Pregnancy or actively breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Obese Sedentary Adults, but otherwise healthy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin Sensitivity
Time Frame: 2-3 hours
|
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity
|
2-3 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Resting Metabolic Rate
Time Frame: 20-30 min
|
20-30 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey F Horowitz, Ph.D., University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
May 26, 2016
Study Completion (Actual)
May 26, 2016
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
October 11, 2011
First Posted (Estimate)
October 14, 2011
Study Record Updates
Last Update Posted (Actual)
March 21, 2022
Last Update Submitted That Met QC Criteria
March 18, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01 DK077966 - OC
- R01DK077966 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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