ObesityApple/PearNCT01748994
Cellular Dynamics of Subcutaneous Fat Distribution in Obese Women
A study testing Pioglitazone in people with Obesity and Metabolic Syndrome, run by Pennington Biomedical Research Center at 2 sites in United States.
Trial summary
The body shape of obese women varies between having the majority of fat either above the waist ("apple" shape) or below the waist ("pear" shape). The study will investigate what restricts: apple"-shaped women from being "pear"-shaped at the cellular level. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Pioglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- You are a pre-menopausal woman between 18-40 years of age
- Your Body Mass Index (BMI, weight-to-height2 ratio) is 27 - 38 kg/m2, inclusive
- The ratio of your waist-to-hip circumferences is either >0.84 ("apple"-type body shape) or <0.77 ("pear"-type body shape)
- You are willing to undergo a drug intervention for 16 weeks
- You are willing to drink heavy water [similar to the ordinary water that is highly enriched in the naturally occurring stable (non-radioactive) form of hydrogen, deuterium; also called deuterium-labeled water] for 8 weeks before the beginning and during the second half of the drug intervention; you will need 24-hours access to a refrigerator for storage of the water.
- You agree to use a double barrier method as a form of birth control to prevent pregnancy. Oral contraceptives (birth control pills) are not allowed in the study. Acceptable methods of birth control are condoms, spermicide, IUD (intrauterine device, must be hormone free - see list in clinic), diaphragm and abstinence. An example of a double barrier method would be condoms plus spermicide, etc.
Who cannot join
- You have gained or lost more than 4.5 lb (2 kg) in the last 3 months
- You have had significant changes in the diet or level of physical activity within the past month
- You have a blood sugar of greater than 100 or a diagnosis of diabetes.
- You have abnormal liver enzyme values from your blood work
- You have a history of heart, kidney, lung, liver, and thyroid disease
- You have an average blood pressure >140/90 at your screening visit
- Have you had a positive test for human immunodeficiency virus (HIV), hepatitis B or hepatitis C?
- You require chronic use of medications including diuretics, steroids, thyroid hormones, and adrenergic-stimulating agents (bronchodilators, nasal decongestants)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70809
About this study
The body shape of obese women varies between having the majority of fat either above the waist ("apple" shape) or below the waist ("pear" shape). The study will investigate what restricts: apple"-shaped women from being "pear"-shaped at the cellular level. Since "pear" shaped women tend to have better health, this study will open the door to future research in regulating body shape and thus improving health.
Read the detailed description
Adipose tissue expandability and the distribution of stored fat in the body are stronger predictors of health risk. A better understanding of the factors that determine regional fat mass growth may lead to developing new strategies for prevention or treatment of metabolic complications of obesity. The objective of this proposal is to study the responsiveness of different fat depots to adipogenic stimulation in upper-body and lower-body obese women.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Pioglitazone, Placebo
- Keywords
- Obesity, Fat distribution, Adipogenesis, Adipocyte, Preadipocyte, Ectopic fat
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
30mg per day for four months
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Administration of placebo to upper- and lower-body obese women Receives: Drug: Placebo |
| Drug | Active comparator | Administration of pioglitazone to upper- and lower-body obese women Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Vivo Adipose Cell Formation (Adipogenesis)
Following the consumption of water labeled with the stable isotope deuterium (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral (thigh) depots will be collected. The 2H from the heavy water is enriched into the DNA of newly synthesized cells. Measures of DNA synthesis (obtained via gas chromatography and mass spectrometry analysis of 2H-enrichment) denote new adipose cell formation, or adipogenesis. The primary outcome is to assess the change (from baseline) in adipose cell formation rates (i.e. adipogenesis) in response to 16-weeks of pioglitazone versus the control group.
Measured: Change from baseline in adipogenesis at 16 weeks
Secondary outcomes (3)
Visceral Adipose Tissue (Percentage of Total Abdominal Adipose Tissue)
The volume of fat tissue around the internal organs in the abdomen (visceral adipose tissue; VAT) and underneath the skin (subcutaneous abdominal adipose tissue; scABD) will be determined by Magnetic Resonance Imaging (MRI) of the abdominal region. VAT:total abdominal AT (TAT) reflects the percentage of abdominal fat that is VAT and is calculated as VAT/(scABD AT + VAT).
Measured: Change from baseline in visceral fat at 16 weeks
Lipid Accretion in the Liver (Intra-hepatic Lipid; IHL)
Lipid accretion in the liver cells will be measured using 1H-MRS of the liver.
Measured: Change from Baseline in intra-hepato-cellular lipid at 16 weeks
Matsuda Index (Measure of Insulin Sensitivity)
Insulin sensitivity (glucose tolerance) will be assessed using an oral 75 g oral glucose tolerance test (OGTT) after an overnight fast. Blood samples will be collected at 0, 30, 60, 90, and 120 min after glucose administration to measure serum glucose and insulin. Insulin sensitivity was calculated using the Matsuda insulin sensitivity index [10,000/ √(glucose 0' x insulin 0') X (mean glucose OGTT x mean insulin OGTT)]. A higher value denotes increased insulin sensitivity.
Measured: Change from Baseline in Matsuda Index at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startFeb 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Ravussin, Pennington Biomedical Research Center
- Investigators
- Eric Ravussin, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748994
- Sponsor's protocol ID
- PBRC 10039
- Other IDs
- 5R01DK090607
- Acronym
- Apple/Pear
- Status last verified
- Apr 2021
- First submitted
- 10 Dec 2012
- Last updated
- 30 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
White U, Fitch MD, Beyl RA, Hellerstein MK, Ravussin E. Adipose depot-specific effects of 16 weeks of pioglitazone on in vivo adipogenesis in women with obesity: a randomised controlled trial. Diabetologia. 2021 Jan;64(1):159-167. doi: 10.1007/s00125-020-05281-7. Epub 2020 Oct 1.
PubMed 33001232White UA, Fitch MD, Beyl RA, Hellerstein MK, Ravussin E. Racial differences in in vivo adipose lipid kinetics in humans. J Lipid Res. 2018 Sep;59(9):1738-1744. doi: 10.1194/jlr.P082628. Epub 2018 Jun 17.
PubMed 29910190White UA, Fitch MD, Beyl RA, Hellerstein MK, Ravussin E. Differences in In Vivo Cellular Kinetics in Abdominal and Femoral Subcutaneous Adipose Tissue in Women. Diabetes. 2016 Jun;65(6):1642-7. doi: 10.2337/db15-1617. Epub 2016 Mar 18.
PubMed 26993068
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Dynamics of Subcutaneous Fat Distribution in Obese Women
- ClinicalTrials.gov ID
- NCT01748994
- Acronym / sponsor ID
- Apple/Pear / PBRC 10039
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- Obesity, Fat distribution, Adipogenesis, Adipocyte, Preadipocyte, Ectopic fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 30 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The body shape of obese women varies between having the majority of fat either above the waist ("apple" shape) or below the waist ("pear" shape). The study will investigate what restricts: apple"-shaped women from being "pear"-shaped at the cellular level. Since "pear" shaped women tend to have better health, this study will open the door to future research in regulating body shape and thus improving health.
Detailed description
Adipose tissue expandability and the distribution of stored fat in the body are stronger predictors of health risk. A better understanding of the factors that determine regional fat mass growth may lead to developing new strategies for prevention or treatment of metabolic complications of obesity. The objective of this proposal is to study the responsiveness of different fat depots to adipogenic stimulation in upper-body and lower-body obese women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAdministration of placebo to upper- and lower-body obese women |
| Drug | Active comparator | Drug: PioglitazoneAdministration of pioglitazone to upper- and lower-body obese women |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- You are a pre-menopausal woman between 18-40 years of age
- Your Body Mass Index (BMI, weight-to-height2 ratio) is 27 - 38 kg/m2, inclusive
- The ratio of your waist-to-hip circumferences is either >0.84 ("apple"-type body shape) or <0.77 ("pear"-type body shape)
- You are willing to undergo a drug intervention for 16 weeks
- You are willing to drink heavy water [similar to the ordinary water that is highly enriched in the naturally occurring stable (non-radioactive) form of hydrogen, deuterium; also called deuterium-labeled water] for 8 weeks before the beginning and during the second half of the drug intervention; you will need 24-hours access to a refrigerator for storage of the water.
Key exclusion criteria (8 listed)
- You have gained or lost more than 4.5 lb (2 kg) in the last 3 months
- You have had significant changes in the diet or level of physical activity within the past month
- You have a blood sugar of greater than 100 or a diagnosis of diabetes.
- You have abnormal liver enzyme values from your blood work
- You have a history of heart, kidney, lung, liver, and thyroid disease
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 |
|---|---|---|
| PioglitazoneAlso: Actos30mg per day for four months | Drug | Drug |
| Placebo | Drug | Placebo |
Primary outcome
In Vivo Adipose Cell Formation (Adipogenesis)
Time frame: Change from baseline in adipogenesis at 16 weeks
Following the consumption of water labeled with the stable isotope deuterium (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral (thigh) depots will be collected. The 2H from the heavy water is enriched into the DNA of newly synthesized cells. Measures of DNA synthesis (obtained via gas chromatography and mass spectrometry analysis of 2H-enrichment) denote new adipose cell formation, or adipogenesis. The primary outcome is to assess the change (from baseline) in adipose cell formation rates (i.e. adipogenesis) in response to 16-weeks of pioglitazone versus the control group.
3 secondary outcomes
Visceral Adipose Tissue (Percentage of Total Abdominal Adipose Tissue)
Time frame: Change from baseline in visceral fat at 16 weeks
Lipid Accretion in the Liver (Intra-hepatic Lipid; IHL)
Time frame: Change from Baseline in intra-hepato-cellular lipid at 16 weeks
Matsuda Index (Measure of Insulin Sensitivity)
Time frame: Change from Baseline in Matsuda Index at 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33001232White U, Fitch MD, Beyl RA, Hellerstein MK, Ravussin E. Adipose depot-specific effects of 16 weeks of pioglitazone on in vivo adipogenesis in women with obesity: a randomised controlled trial. Diabetologia. 2021 Jan;64(1):159-167. doi: 10.1007/s00125-020-05281-7. Epub 2020 Oct 1.
- Derived from this study: PubMed 29910190White UA, Fitch MD, Beyl RA, Hellerstein MK, Ravussin E. Racial differences in in vivo adipose lipid kinetics in humans. J Lipid Res. 2018 Sep;59(9):1738-1744. doi: 10.1194/jlr.P082628. Epub 2018 Jun 17.
- Derived from this study: PubMed 26993068White UA, Fitch MD, Beyl RA, Hellerstein MK, Ravussin E. Differences in In Vivo Cellular Kinetics in Abdominal and Femoral Subcutaneous Adipose Tissue in Women. Diabetes. 2016 Jun;65(6):1642-7. doi: 10.2337/db15-1617. Epub 2016 Mar 18.
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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.
Eric Ravussin, PhD principal investigator
Pennington Biomedical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pioglitazone in people with Obesity and Metabolic Syndrome, run by Pennington Biomedical Research Center at 2 sites 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 6 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
In Vivo Adipose Cell Formation (Adipogenesis) (time frame: Change from baseline in adipogenesis at 16 weeks). 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 NCT01748994, 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 30 Apr 2021.