An interventional study of Pioglitazone and Placebo in Obesity and Metabolic Syndrome, sponsored by Pennington Biomedical Research Center. Completed at 2 sites in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Basic science
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.
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 63 is close to the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administration of placebo to upper- and lower-body obese women
Drug: Placebo
Administration of pioglitazone to upper- and lower-body obese women
Drug: Pioglitazone
30mg per day for four months
Also known as: Actos
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.
Time frame: Change from baseline in adipogenesis at 16 weeks
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).
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline in Matsuda Index at 16 weeks
| Milestone | Placebo | Drug |
|---|---|---|
| Started | 31 | 32 |
| Completed | 23 | 26 |
| Not completed | 8 | 6 |
| Withdrew: Lost to follow-up | 8 | 6 |
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.
| percent | Placebo | Drug |
|---|---|---|
| Abdominal | -0.3 ± 1.5 | 1.8 ± 1.4 |
| Femoral | -1.2 ± 1.1 | 2.1 ± 1.1 |
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).
| percent | Placebo | Drug |
|---|---|---|
| Visceral Adipose Tissue (Percentage of Total Abdominal Adipose Tissue) | 0.5 ± 0.3 | -0.8 ± 0.3 |
Lipid accretion in the liver cells will be measured using 1H-MRS of the liver.
| percent | Placebo | Drug |
|---|---|---|
| Lipid Accretion in the Liver (Intra-hepatic Lipid; IHL) | -0.7 ± 1.2 | -2.0 ± 1.2 |
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.
| index | Placebo | Drug |
|---|---|---|
| Matsuda Index (Measure of Insulin Sensitivity) | -0.39 ± 0.41 | 0.80 ± 0.40 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/31 (0%) | 15/31 (48.4%) |
| Drug | — | 0/32 (0%) | 15/32 (46.9%) |
| Event | Placebo | Drug |
|---|---|---|
| Skin irritationSkin and subcutaneous tissue disorders | 6/31 | 6/32 |
| Vertigo (dizziness)Nervous system disorders | 4/31 | 6/32 |
| Gastrointestinal issuesGastrointestinal disorders | 4/31 | 3/32 |
| Skin hematomaSkin and subcutaneous tissue disorders | 1/31 | 0/32 |
Of the 23 participants in the Placebo group, N=3 did not have adipose tissue biopsy data, and of the 26 participants in the Drug group, N=5 did not have adipose tissue biopsy data. Therefore, the Baseline Analysis only included N=20 and N=21, respectively.
| Age, Categorical(Participants) | Placebo | Drug | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 21 | 41 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo | Drug | Total |
|---|---|---|---|
| Female | 20 | 21 | 41 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Drug | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 20 | 21 | 41 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Drug | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 10 | 20 |
| White | 10 | 11 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Drug | Total |
|---|---|---|---|
| United States | 20 | 21 | 41 |
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pennington Biomedical Research Center