ObesityISISNCT00704197
"ISIS" Study of Sex Differences in Characteristics of Adiposity and Metabolism
An observational study of Obesity and Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to characterize differences in the structure and function of the body fat from two different parts of the body in young, healthy men and women. We will also compare how differences in metabolism relate to characteristics of body fat and its functions. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents of Baton Rouge
Who may be able to join
- Diabetic men and women ages 40 to 60, inclusive and healthy men and women ages 20 to 35, inclusive.
- Body mass index (a ratio of height to weight) less than 25 kg/m2 (lean group) or 27 to 35 kg/m2 (overweight/obese group).
- Not involved in regular physical activity (more than 3 times per week).
- Women must have regular menstrual cycles (1 menstrual bleeding each month).
Who cannot join
- For men in the overweight/obese group, you have a waist circumference less than 102cm (40 inches).
- You smoke.
- You have liver, kidney, thyroid or heart diseases, or cancer.
- You are claustrophobic.
- You have metal objects in your body such as implanted rods or surgical clips.
- If you are not diabetic and you are taking steroids, protease inhibitors, statins, antihypertensives or medications known to alter glucose or lipid metabolism.
Show all 12Show fewer
- If you are diabetic and you are taking steroids, protease inhibitors, or injectable antihyperglycemic medications (oral diabetic meds are allowed.)
- If you are a woman, you are pregnant or breast feeding or trying to become pregnant (women who become pregnant throughout the study will be excluded).
- If you are a woman, you are using hormonal contraceptives or have anovulation, androgen excess or irregular menstrual cycles (less than 1 cycle per month).
- You have previously had a BMI >35 kg/m2.
- You are not able to eat the foods provided by PBRC.
- If your weight has not been stable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Study of Sex Differences in Characteristics of Adiposity and Metabolism
The purpose of this study is to characterize differences in the structure and function of the body fat from two different parts of the body in young, healthy men and women. We will also compare how differences in metabolism relate to characteristics of body fat and its functions.
Read the detailed description
Following screening, the study comprises of a total of 3 clinic visits (2 outpatient visits, and 1 overnight stay) completed during a 2 week period. For the outpatient visits, body composition (by DEXA), visceral fat (by CT), ectopic fat (by MRS and CT) and aerobic fitness (by VO2max test) will be measured. Women will also have ovarian parameters (follicle size and number) measured during the MR scans. Following an overnight stay in the inpatient unit, insulin sensitivity (by euglycemic hyperinsulinemic clamp), interstitial lipolysis (by microdialysis), whole body lipolysis and glycolysis (by stable isotopes), abdominal adipose tissue oxygen content (Hunt and Direct Methods) will be measured and a subcutaneous fat biopsy of the abdominal and gluteo-femoral tissue will be collected. Women will complete all testing in the follicular phase of the menstrual cycle.
- Medical subject headings
- Obesity, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess sex differences in adipose tissue gene expression in different fat depots
Measured: baseline
Secondary outcomes (1)
To assess sex differences in other characteristics of adipose tissue structure and function in different fat depots across sex including: preadipocyte kinetics; lipolysis and lipogenesis; macrophage content; and tissue oxygenation
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2013
- Study completionJan 2016
Why it stopped: Study has not been updated since 2016 and PI (Steven R Smith, M.D.) left PBRC. Angela 09/13/2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Steven R Smith, M.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704197
- Sponsor's protocol ID
- PBRC 27010
- Acronym
- ISIS
- Status last verified
- Sep 2022
- First submitted
- 20 Jun 2008
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nunez Lopez YO, Garufi G, Pasarica M, Seyhan AA. Elevated and Correlated Expressions of miR-24, miR-30d, miR-146a, and SFRP-4 in Human Abdominal Adipose Tissue Play a Role in Adiposity and Insulin Resistance. Int J Endocrinol. 2018 Mar 12;2018:7351902. doi: 10.1155/2018/7351902. eCollection 2018.
PubMed 29721017Divoux A, Xie H, Li JL, Karastergiou K, Perera RJ, Chang RJ, Fried SK, Smith SR. MicroRNA-196 Regulates HOX Gene Expression in Human Gluteal Adipose Tissue. Obesity (Silver Spring). 2017 Aug;25(8):1375-1383. doi: 10.1002/oby.21896. Epub 2017 Jun 25.
PubMed 28649807Pasarica M, Rood J, Ravussin E, Schwarz JM, Smith SR, Redman LM. Reduced oxygenation in human obese adipose tissue is associated with impaired insulin suppression of lipolysis. J Clin Endocrinol Metab. 2010 Aug;95(8):4052-5. doi: 10.1210/jc.2009-2377. Epub 2010 May 13.
PubMed 20466783
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Sex Differences in Characteristics of Adiposity and Metabolism
- ClinicalTrials.gov ID
- NCT00704197
- Acronym / sponsor ID
- ISIS / PBRC 27010
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study has not been updated since 2016 and PI (Steven R Smith, M.D.) left PBRC. Angela 09/13/2022
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- University of Maryland, University of California, San Diego
- Study start
- Aug 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Jun 2008 (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 is to characterize differences in the structure and function of the body fat from two different parts of the body in young, healthy men and women. We will also compare how differences in metabolism relate to characteristics of body fat and its functions.
Detailed description
Following screening, the study comprises of a total of 3 clinic visits (2 outpatient visits, and 1 overnight stay) completed during a 2 week period. For the outpatient visits, body composition (by DEXA), visceral fat (by CT), ectopic fat (by MRS and CT) and aerobic fitness (by VO2max test) will be measured. Women will also have ovarian parameters (follicle size and number) measured during the MR scans. Following an overnight stay in the inpatient unit, insulin sensitivity (by euglycemic hyperinsulinemic clamp), interstitial lipolysis (by microdialysis), whole body lipolysis and glycolysis (by stable isotopes), abdominal adipose tissue oxygen content (Hunt and Direct Methods) will be measured and a subcutaneous fat biopsy of the abdominal and gluteo-femoral tissue will be collected. Women will complete all testing in the follicular phase of the menstrual cycle.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents of Baton Rouge
Key inclusion criteria (4 listed)
- Diabetic men and women ages 40 to 60, inclusive and healthy men and women ages 20 to 35, inclusive.
- Body mass index (a ratio of height to weight) less than 25 kg/m2 (lean group) or 27 to 35 kg/m2 (overweight/obese group).
- Not involved in regular physical activity (more than 3 times per week).
- Women must have regular menstrual cycles (1 menstrual bleeding each month).
Key exclusion criteria (12 listed)
- For men in the overweight/obese group, you have a waist circumference less than 102cm (40 inches).
- You smoke.
- You have liver, kidney, thyroid or heart diseases, or cancer.
- You are claustrophobic.
- You have metal objects in your body such as implanted rods or surgical clips.
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
To assess sex differences in adipose tissue gene expression in different fat depots
Time frame: baseline
1 secondary outcome
To assess sex differences in other characteristics of adipose tissue structure and function in different fat depots across sex including: preadipocyte kinetics; lipolysis and lipogenesis; macrophage content; and tissue oxygenation
Time frame: baseline
Results and safety
The study was stopped early (reason given: Study has not been updated since 2016 and PI (Steven R Smith, M.D.) left PBRC. Angela 09/13/2022). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Derived from this study: PubMed 29721017Nunez Lopez YO, Garufi G, Pasarica M, Seyhan AA. Elevated and Correlated Expressions of miR-24, miR-30d, miR-146a, and SFRP-4 in Human Abdominal Adipose Tissue Play a Role in Adiposity and Insulin Resistance. Int J Endocrinol. 2018 Mar 12;2018:7351902. doi: 10.1155/2018/7351902. eCollection 2018.
- Derived from this study: PubMed 28649807Divoux A, Xie H, Li JL, Karastergiou K, Perera RJ, Chang RJ, Fried SK, Smith SR. MicroRNA-196 Regulates HOX Gene Expression in Human Gluteal Adipose Tissue. Obesity (Silver Spring). 2017 Aug;25(8):1375-1383. doi: 10.1002/oby.21896. Epub 2017 Jun 25.
- Derived from this study: PubMed 20466783Pasarica M, Rood J, Ravussin E, Schwarz JM, Smith SR, Redman LM. Reduced oxygenation in human obese adipose tissue is associated with impaired insulin suppression of lipolysis. J Clin Endocrinol Metab. 2010 Aug;95(8):4052-5. doi: 10.1210/jc.2009-2377. Epub 2010 May 13.
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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.
Steven R Smith, M.D. principal investigator
Pennington Biomedical Research Center
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 and Diabetes, run by Pennington Biomedical Research Center 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 12 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: stopped early, as of the sponsor's last update on 15 Sep 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 was stopped early (reason given: Study has not been updated since 2016 and PI (Steven R Smith, M.D.) left PBRC. Angela 09/13/2022). Results are not available in the source record.
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?
To assess sex differences in adipose tissue gene expression in different fat depots (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 NCT00704197, which also lists 3 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 Sep 2022.