Insulin ResistancePhase 1NCT00285844
Integrating the Genetic and Metabolic Faces of Obesity
A Phase 1 study testing weight loss and thiazolidinedione in people with Insulin Resistance and Obesity, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is to determine why some obese individuals develop insulin resistance and others do not. We hypothesize that an impairment in differentiation of fat cells (adipocytes) is responsible for the development of insulin resistance in select obese individuals. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity, Metabolic Syndrome
- What is being tested?
- weight loss and thiazolidinedione
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2012
- Phase
- Phase 1
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nondiabetic defined as fasting plasma glucose < 126 mg/dL
- body mass index 27 to 35 kg/m2
- no major organ diseases
- able to come to Stanford for regular clinical research center visits
- English speaking or has own translator
Who cannot join
- pregnancy/lactation
- history of eating disorder or major psychiatric illness
- allergy to thiazolidinedione
- elevation of liver enzymes (> 2.5 times upper normal limit)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to determine why some obese individuals develop insulin resistance and others do not. We hypothesize that an impairment in differentiation of fat cells (adipocytes) is responsible for the development of insulin resistance in select obese individuals. This study will evaluate obese individuals at baseline with respect to characteristics of adipocytes, including gene expression, and will then entail randomizing subjects to either weight loss or treatment with an insulin sensitizing drug (pioglitazone). Changes in insulin resistance will be associated with changes in adipocyte morphology and gene expression.
Read the detailed description
Healthy overweight/obese individuals will be screened for insulin resistance. Both insulin resistant individuals and insulin sensitive individuals (to serve as controls) will be eligible to enroll. Fat cel biopsy and CT scan of the abdomen is required at baseline and after an intervention with either weight loss or pioglitazone (drug to improve insulin resistance). Subjects will repeat insulin resistance test after the intervention as well. Subjects will learn much about their metabolism in this study, and will have an opportunity to improve their insulin resistance.
- Conditions
- Insulin Resistance, Obesity, Metabolic Syndrome
- Being tested
- weight loss, thiazolidinedione
- Keywords
- obesity, insulin resistance, thiazolidinedione, weight loss, adipose tissue, metabolic syndrome, diabetes prevention, cardiovascular disease prevention
- Medical subject headings
- Insulin Resistance, Obesity, Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight lossBehavioural
thiazolidinedioneDrug
| Study group | Role | What they receive |
|---|---|---|
| pioglitazone | Experimental | IR and IS subjects will be randomized to pioglitazone 45 mg daily for 16 wks for comparison with dietary weight loss intervention Receives: Drug: thiazolidinedione |
| Dietary Weight Loss | Experimental | IR and IS subjects will be randomized to dietary weight loss for 16 wks for comparison to pioglitazone intervention Receives: Behavioral: weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose Cell Size Distribution
Measured: 2005-2012
Secondary outcomes (1)
Adipose Tissue Gene Expression
Measured: 2005-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startOct 2005
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Stanford 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracey McLaughlin, Stanford University
- Investigators
- Tracey McLaughlin, MD, MS, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285844
- Sponsor's protocol ID
- RDK071309
- Status last verified
- Dec 2024
- First submitted
- 31 Jan 2006
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McLaughlin T, Liu LF, Lamendola C, Shen L, Morton J, Rivas H, Winer D, Tolentino L, Choi O, Zhang H, Hui Yen Chng M, Engleman E. T-cell profile in adipose tissue is associated with insulin resistance and systemic inflammation in humans. Arterioscler Thromb Vasc Biol. 2014 Dec;34(12):2637-43. doi: 10.1161/ATVBAHA.114.304636. Epub 2014 Oct 23.
PubMed 25341798McLaughlin T, Lamendola C, Liu A, Abbasi F. Preferential fat deposition in subcutaneous versus visceral depots is associated with insulin sensitivity. J Clin Endocrinol Metab. 2011 Nov;96(11):E1756-60. doi: 10.1210/jc.2011-0615. Epub 2011 Aug 24.
PubMed 21865361McLaughlin T, Deng A, Yee G, Lamendola C, Reaven G, Tsao PS, Cushman SW, Sherman A. Inflammation in subcutaneous adipose tissue: relationship to adipose cell size. Diabetologia. 2010 Feb;53(2):369-77. doi: 10.1007/s00125-009-1496-3. Epub 2009 Oct 9.
PubMed 19816674McLaughlin T, Deng A, Gonzales O, Aillaud M, Yee G, Lamendola C, Abbasi F, Connolly AJ, Sherman A, Cushman SW, Reaven G, Tsao PS. Insulin resistance is associated with a modest increase in inflammation in subcutaneous adipose tissue of moderately obese women. Diabetologia. 2008 Dec;51(12):2303-8. doi: 10.1007/s00125-008-1148-z. Epub 2008 Sep 30.
PubMed 18825363
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating the Genetic and Metabolic Faces of Obesity
- ClinicalTrials.gov ID
- NCT00285844
- Acronym / sponsor ID
- RDK071309
- Conditions
- Insulin Resistance, Obesity, Metabolic Syndrome
- Keywords
- obesity, insulin resistance, thiazolidinedione, weight loss, adipose tissue, metabolic syndrome, diabetes prevention, cardiovascular disease prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2005 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Feb 2006 (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 goal of this study is to determine why some obese individuals develop insulin resistance and others do not. We hypothesize that an impairment in differentiation of fat cells (adipocytes) is responsible for the development of insulin resistance in select obese individuals. This study will evaluate obese individuals at baseline with respect to characteristics of adipocytes, including gene expression, and will then entail randomizing subjects to either weight loss or treatment with an insulin sensitizing drug (pioglitazone). Changes in insulin resistance will be associated with changes in adipocyte morphology and gene expression.
Detailed description
Healthy overweight/obese individuals will be screened for insulin resistance. Both insulin resistant individuals and insulin sensitive individuals (to serve as controls) will be eligible to enroll. Fat cel biopsy and CT scan of the abdomen is required at baseline and after an intervention with either weight loss or pioglitazone (drug to improve insulin resistance). Subjects will repeat insulin resistance test after the intervention as well. Subjects will learn much about their metabolism in this study, and will have an opportunity to improve their insulin resistance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pioglitazone | Experimental | Drug: thiazolidinedioneIR and IS subjects will be randomized to pioglitazone 45 mg daily for 16 wks for comparison with dietary weight loss intervention |
| Dietary Weight Loss | Experimental | Behavioral: weight lossIR and IS subjects will be randomized to dietary weight loss for 16 wks for comparison to pioglitazone intervention |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- nondiabetic defined as fasting plasma glucose < 126 mg/dL
- body mass index 27 to 35 kg/m2
- no major organ diseases
- able to come to Stanford for regular clinical research center visits
- English speaking or has own translator
Key exclusion criteria (4 listed)
- pregnancy/lactation
- history of eating disorder or major psychiatric illness
- allergy to thiazolidinedione
- elevation of liver enzymes (> 2.5 times upper normal limit)
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 |
|---|---|---|
| weight loss | Behavioural | Dietary Weight Loss |
| thiazolidinedione | Drug | pioglitazone |
Primary outcome
Adipose Cell Size Distribution
Time frame: 2005-2012
1 secondary outcome
Adipose Tissue Gene Expression
Time frame: 2005-2013
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 4 Dec 2024.
- Derived from this study: PubMed 25341798McLaughlin T, Liu LF, Lamendola C, Shen L, Morton J, Rivas H, Winer D, Tolentino L, Choi O, Zhang H, Hui Yen Chng M, Engleman E. T-cell profile in adipose tissue is associated with insulin resistance and systemic inflammation in humans. Arterioscler Thromb Vasc Biol. 2014 Dec;34(12):2637-43. doi: 10.1161/ATVBAHA.114.304636. Epub 2014 Oct 23.
- Derived from this study: PubMed 21865361McLaughlin T, Lamendola C, Liu A, Abbasi F. Preferential fat deposition in subcutaneous versus visceral depots is associated with insulin sensitivity. J Clin Endocrinol Metab. 2011 Nov;96(11):E1756-60. doi: 10.1210/jc.2011-0615. Epub 2011 Aug 24.
- Derived from this study: PubMed 19816674McLaughlin T, Deng A, Yee G, Lamendola C, Reaven G, Tsao PS, Cushman SW, Sherman A. Inflammation in subcutaneous adipose tissue: relationship to adipose cell size. Diabetologia. 2010 Feb;53(2):369-77. doi: 10.1007/s00125-009-1496-3. Epub 2009 Oct 9.
- Derived from this study: PubMed 18825363McLaughlin T, Deng A, Gonzales O, Aillaud M, Yee G, Lamendola C, Abbasi F, Connolly AJ, Sherman A, Cushman SW, Reaven G, Tsao PS. Insulin resistance is associated with a modest increase in inflammation in subcutaneous adipose tissue of moderately obese women. Diabetologia. 2008 Dec;51(12):2303-8. doi: 10.1007/s00125-008-1148-z. Epub 2008 Sep 30.
- 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.
Tracey McLaughlin, MD, MS study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing weight loss and thiazolidinedione in people with Insulin Resistance and Obesity, run by Stanford 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 5 inclusion and 4 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 4 Dec 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adipose Cell Size Distribution (time frame: 2005-2012). 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 NCT00285844, which also lists 4 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 4 Dec 2024.