ObesityNCT01452048
Relationship Between Systemic Fatty Acid Availability and Insulin Sensitivity
An observational study of Obesity, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 26 May 2016
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: UM Health System patients from Dr. Amy Rothberg and colleagues UM Investigational Weight Management Clinic (IWMC) Community Sample
Who may be able to join
- Body mass index [BMI]: 35-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)
Who cannot join
- Weight instability ≥ ±5 lbs. in past month; medications known to affect lipid and/or glucose metabolism; Pregnancy or actively breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Clincal Research Unit
Ann Arbor, Michigan, 48109
About this study
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.
- Conditions
- Obesity
- Keywords
- insulin sensitivity, fatty acid metabolism
- Medical subject headings
- Obesity, Insulin Resistance
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 |
|---|---|---|
| Obese Sedentary Adults, but otherwise healthy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity
Measured: 2-3 hours
Secondary outcomes (1)
Resting Metabolic Rate
Measured: 20-30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startSep 2011
- Primary completion26 May 2016
- Study completion26 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey F Horowitz, University of Michigan
- Investigators
- Jeffrey F Horowitz, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452048
- Sponsor's protocol ID
- R01 DK077966 - OC
- Other IDs
- R01DK077966
- Status last verified
- Mar 2022
- First submitted
- 11 Oct 2011
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Systemic Fatty Acid Availability and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT01452048
- Acronym / sponsor ID
- R01 DK077966 - OC
- Conditions
- Obesity
- Keywords
- insulin sensitivity, fatty acid metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2011
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 26 May 2016 (actual)
- First posted
- 14 Oct 2011 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese Sedentary Adults, but otherwise healthy | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- UM Health System patients from Dr. Amy Rothberg and colleagues UM Investigational Weight Management Clinic (IWMC) Community Sample
Key inclusion criteria (1 listed)
- Body mass index [BMI]: 35-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)
Key exclusion criteria (1 listed)
- Weight instability ≥ ±5 lbs. in past month; medications known to affect lipid and/or glucose metabolism; Pregnancy or actively breast feeding
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
Insulin Sensitivity
Time frame: 2-3 hours
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity
1 secondary outcome
Resting Metabolic Rate
Time frame: 20-30 min
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 21 Mar 2022.
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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.
Jeffrey F Horowitz, Ph.D. principal investigator
University of Michigan
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 Obesity, run by University of Michigan 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 1 inclusion and 1 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 21 Mar 2022. 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?
Insulin Sensitivity (time frame: 2-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2022.