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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK090607 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Administration of placebo to upper- and lower-body obese women |
|
| Drug | Active Comparator | Administration of pioglitazone to upper- and lower-body obese women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | 30mg per day for four months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline in adipogenesis at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Ravussin, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States | ||
| Pennington Biomedical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33001232 | Derived | 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. | |
| 29910190 | Derived | White 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Administration of placebo to upper- and lower-body obese women Placebo |
| FG001 | Drug | Administration of pioglitazone to upper- and lower-body obese women Pioglitazone: 30mg per day for four months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Administration of placebo to upper- and lower-body obese women Placebo |
| BG001 | Drug | Administration of pioglitazone to upper- and lower-body obese women Pioglitazone: 30mg per day for four months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 Primary Outcome Analysis only included N=20 and N=21, respectively. | Posted | Least Squares Mean | Standard Error | percent | Change from baseline in adipogenesis at 16 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Administration of placebo to upper- and lower-body obese women Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo (dizziness) | Nervous system disorders | Non-systematic Assessment | Participants reported feelings of dizziness and light-headedness after drinking the deuterium-labeled water. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Ravussin | Pennington Biomedical Research Center | 225-763-3186 | eric.ravussin@pbrc.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug |
|
| 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. | 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. | Change from Baseline in Matsuda Index at 16 weeks |
| Baton Rouge |
| Louisiana |
| 70809 |
| United States |
| 26993068 | Derived | White 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo |
| OG001 | Drug | Pioglitazone |
|
|
| Secondary | 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). | 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 Secondary Outcome Analysis only included N=20 and N=21, respectively. | Posted | Least Squares Mean | Standard Error | percent | Change from baseline in visceral fat at 16 weeks |
|
|
|
| Secondary | Lipid Accretion in the Liver (Intra-hepatic Lipid; IHL) | Lipid accretion in the liver cells will be measured using 1H-MRS of the liver. | 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 Secondary Outcome Analysis only included N=20 and N=21, respectively. | Posted | Least Squares Mean | Standard Error | percent | Change from Baseline in intra-hepato-cellular lipid at 16 weeks |
|
|
|
| Secondary | 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. | 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 Secondary Outcome Analysis only included N=20 and N=21, respectively. | Posted | Least Squares Mean | Standard Error | index | Change from Baseline in Matsuda Index at 16 weeks |
|
|
|
| 0 |
| 31 |
| 15 |
| 31 |
| EG001 | Drug | Administration of pioglitazone to upper- and lower-body obese women Pioglitazone: 30mg per day for four months | 0 | 32 | 15 | 32 |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participants reported skin irritation, including inflammation, rash, and pain, at the site of the adipose tissue biopsy. |
|
| Gastrointestinal issues | Gastrointestinal disorders | Non-systematic Assessment | Patients reported gastrointestinal issues, including nausea, vomiting, constipation, loss of appetite, and flatulence during the study. |
|
| Skin hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | A participant reported a hematoma after the adipose tissue biopsy. |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |