Insulin ResistanceNCT02196051
Basic Research Study to Examine the Relation Between Muscle Insulin Resistance and Lipid Production in the Liver.
A study testing one bout of 45 minutes exercise in people with Insulin Resistance, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study was to examine the pathophysiology of insulin resistance and the relation to the metabolic syndrome in humans. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- one bout of 45 minutes exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2008to 30 Jan 2012
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index < 29 kg/m2
- No regular exercise routine
- Non-smokers
- Absence of systemic and organ disease.
Who cannot join
- Hematocrit < 35 vol%
- History of claustrophobia
- Ferromagnetic implants
- Regular exercise regimen
- Not weight stable
- Any significant hematological, neurological, musculoskeletal or endocrine disease (including diabetes mellitus)
- Any significant cardiovascular condition, including confirmed CAD and prior cardiovascular events
- Taking coumadin as anticoagulant therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
YCCI/YNNH Hospital Research Unit
New Haven, Connecticut, 06520
About this study
Official title: Lipid and Carbohydrate Metabolism: Effects of Exercise
The purpose of this study was to examine the pathophysiology of insulin resistance and the relation to the metabolic syndrome in humans.
Read the detailed description
In this study insulin resistant (IR), young offspring of parents with type 2 diabetes (18-46 years) and healthy, lean elderly individuals (65-90 years) underwent 1H/13C MRS measurements of liver and muscle lipid and glycogen content before and after a high carbohydrate meal challenge. Hepatic de novo lipogenesis was determined as the incorporation of deuterium, from deuterium labeled water (2H2O), into plasma triglycerides 5. These metabolic studies were performed in 2 sets: Study Part 1: Resting, Study Part 2: After 1 bout of 45 minutes exercise.
The study has been completed and published as two papers: August 16, 2011 and July 24, 2012.
- Conditions
- Insulin Resistance
- Being tested
- one bout of 45 minutes exercise
- Keywords
- Insulin resistance, Exercise, de novo lipogenesis, NAFLD, Magnetic Resonance Spectroscopy
- Medical subject headings
- Insulin Resistance, Motor Activity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one bout of 45 minutes exerciseOther
45 minutes of exercise on an elliptical exercise machine
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | Participants engaged in a single bout of elliptical exercise for 45 minutes (3 times 15 minutes spaced by 5 minutes rest) at baseline. Subjects will be studied before and after this one bout to measure hepatic de novo lipogenesis. Hepatic de novo lipogenesis will be compared pre and post to examine whether acutely improving muscle glucose uptake will decrease hepatic de novo lipogenesis as the glucose is taken up by muscle and not directed to the liver. Receives: Other: one bout of 45 minutes exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in de novo lipogenesis
At the baseline assessment, de novo lipogenesis was assessed after a high carbohydrate meal and a drink of heavy water. Muscle glycogen and lipid contents were measured pre- and post meal using 1H/13C MRS and de novo lipogenesis was assessed from the heavy water incorporation into blood lipid in samples collected overnight.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study start1 Jan 2008
- Primary completion30 Jan 2012
- Study completion30 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kitt Petersen, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196051
- Sponsor's protocol ID
- 0710003207
- Other IDs
- R56AG023686
- Status last verified
- Aug 2024
- First submitted
- 25 Jun 2014
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rabol R, Petersen KF, Dufour S, Flannery C, Shulman GI. Reversal of muscle insulin resistance with exercise reduces postprandial hepatic de novo lipogenesis in insulin resistant individuals. Proc Natl Acad Sci U S A. 2011 Aug 16;108(33):13705-9. doi: 10.1073/pnas.1110105108. Epub 2011 Aug 1.
PubMed 21808028Flannery C, Dufour S, Rabol R, Shulman GI, Petersen KF. Skeletal muscle insulin resistance promotes increased hepatic de novo lipogenesis, hyperlipidemia, and hepatic steatosis in the elderly. Diabetes. 2012 Nov;61(11):2711-7. doi: 10.2337/db12-0206. Epub 2012 Jul 24.
PubMed 22829450
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid and Carbohydrate Metabolism: Effects of Exercise
- ClinicalTrials.gov ID
- NCT02196051
- Acronym / sponsor ID
- 0710003207
- Conditions
- Insulin Resistance
- Keywords
- Insulin resistance, Exercise, de novo lipogenesis, NAFLD, Magnetic Resonance Spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 30 Jan 2012 (actual)
- Study completion
- 30 Jan 2012 (actual)
- First posted
- 21 Jul 2014 (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 purpose of this study was to examine the pathophysiology of insulin resistance and the relation to the metabolic syndrome in humans.
Detailed description
In this study insulin resistant (IR), young offspring of parents with type 2 diabetes (18-46 years) and healthy, lean elderly individuals (65-90 years) underwent 1H/13C MRS measurements of liver and muscle lipid and glycogen content before and after a high carbohydrate meal challenge. Hepatic de novo lipogenesis was determined as the incorporation of deuterium, from deuterium labeled water (2H2O), into plasma triglycerides 5. These metabolic studies were performed in 2 sets: Study Part 1: Resting, Study Part 2: After 1 bout of 45 minutes exercise.
The study has been completed and published as two papers: August 16, 2011 and July 24, 2012.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Other: one bout of 45 minutes exerciseParticipants engaged in a single bout of elliptical exercise for 45 minutes (3 times 15 minutes spaced by 5 minutes rest) at baseline. Subjects will be studied before and after this one bout to measure hepatic de novo lipogenesis. Hepatic de novo lipogenesis will be compared pre and post to examine whether acutely improving muscle glucose uptake will decrease hepatic de novo lipogenesis as the glucose is taken up by muscle and not directed to the liver. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index < 29 kg/m2
- No regular exercise routine
- Non-smokers
- Absence of systemic and organ disease.
Key exclusion criteria (8 listed)
- Hematocrit < 35 vol%
- History of claustrophobia
- Ferromagnetic implants
- Regular exercise regimen
- Not weight stable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one bout of 45 minutes exercise45 minutes of exercise on an elliptical exercise machine | Other | Exercise Training |
Primary outcome
change in de novo lipogenesis
Time frame: Baseline
At the baseline assessment, de novo lipogenesis was assessed after a high carbohydrate meal and a drink of heavy water. Muscle glycogen and lipid contents were measured pre- and post meal using 1H/13C MRS and de novo lipogenesis was assessed from the heavy water incorporation into blood lipid in samples collected overnight.
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 15 Aug 2024.
- Results publication: PubMed 21808028Rabol R, Petersen KF, Dufour S, Flannery C, Shulman GI. Reversal of muscle insulin resistance with exercise reduces postprandial hepatic de novo lipogenesis in insulin resistant individuals. Proc Natl Acad Sci U S A. 2011 Aug 16;108(33):13705-9. doi: 10.1073/pnas.1110105108. Epub 2011 Aug 1.
- Results publication: PubMed 22829450Flannery C, Dufour S, Rabol R, Shulman GI, Petersen KF. Skeletal muscle insulin resistance promotes increased hepatic de novo lipogenesis, hyperlipidemia, and hepatic steatosis in the elderly. Diabetes. 2012 Nov;61(11):2711-7. doi: 10.2337/db12-0206. Epub 2012 Jul 24.
- Individual participant dataSharing planned: No
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Healthy Volunteer
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.
Kitt Petersen, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one bout of 45 minutes exercise in people with Insulin Resistance, run by Yale University 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 4 inclusion and 8 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 15 Aug 2024. 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?
change in de novo lipogenesis (time frame: Baseline). 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 NCT02196051, which also lists 2 linked publications.
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 15 Aug 2024.