| ID | Type | Description | Link |
|---|---|---|---|
| 1K23RRO24470-01 |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on pancreatic fat content and bone turnover markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pioglitazone | Experimental | pioglitazone tablet 45 mg once daily |
|
| placebo pill | Placebo Comparator | placebo pill once daily (look-alike pill which contains no active ingredients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pioglitazone | Drug | pioglitazone 45 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic Fat Content | Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system. | 12 months |
| Bone Turnover Marker - Intact Parathyroid Hormone (PTH) | Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. . | 12 months |
| Bone Turnover Marker - Plasma 25-hydroxyvitamin D | Plasma 25-hydroxyvitamin D was determined by radioimmunoassay | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Beta-cell Function | Changes in B-cell function as measured by acute insulin release to glucose (AIRg) | 12 months |
| Hepatic Fat Content | Hepatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone | pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects |
| FG001 | Placebo Pill | placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone | pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 |
| BG001 | Placebo Pill | placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 |
| 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 | Pancreatic Fat Content | Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system. | Posted | Median | Inter-Quartile Range | Percentage of fat | 12 months |
|
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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 | Pioglitazone | pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteremia with Streptococcus pneumoniae | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lose consciousness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ildiko Lingvay | UT Southwestern Medical Center | 214-648-2779 | ildiko.lingvay@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D003920 | Diabetes Mellitus |
| 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 | one daily |
|
|
| 12 months |
| Subcutaneous Fat Area | Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level. | 12 months |
| Visceral Fat Area | Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level. | 12 months |
| Bone Mineral Density | Areal Bone Mineral Density at the L2-L4 antero-posterior lumbar spine, left femoral neck and total hip were measured by DXA scan using a Hologic Discovery Instrument scanner. | 12 months |
| Disposition Index | Disposition index is a measure of insulin secretion multiplied by insulin sensitivity, both derived from intravenous glucose tolerance test. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose | 12 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Bone Turnover Marker - Intact Parathyroid Hormone (PTH) | Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. . | Posted | Median | Inter-Quartile Range | pg/mL | 12 months |
|
|
|
| Primary | Bone Turnover Marker - Plasma 25-hydroxyvitamin D | Plasma 25-hydroxyvitamin D was determined by radioimmunoassay | Posted | Median | Inter-Quartile Range | ng/mL | 12 months |
|
|
|
| Secondary | Beta-cell Function | Changes in B-cell function as measured by acute insulin release to glucose (AIRg) | Posted | Median | Inter-Quartile Range | microUnits/mL x min | 12 months |
|
|
|
| Secondary | Hepatic Fat Content | Hepatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system. | Posted | Median | Inter-Quartile Range | percentage | 12 months |
|
|
|
| Secondary | Subcutaneous Fat Area | Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level. | Posted | Mean | Standard Deviation | cm^2 | 12 months |
|
|
|
| Secondary | Visceral Fat Area | Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level. | Posted | Mean | Standard Deviation | cm^2 | 12 months |
|
|
|
| Secondary | Bone Mineral Density | Areal Bone Mineral Density at the L2-L4 antero-posterior lumbar spine, left femoral neck and total hip were measured by DXA scan using a Hologic Discovery Instrument scanner. | Posted | Mean | Standard Deviation | g/cm^2 | 12 months |
|
|
|
| Secondary | Disposition Index | Disposition index is a measure of insulin secretion multiplied by insulin sensitivity, both derived from intravenous glucose tolerance test. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose | Posted | Median | Inter-Quartile Range | Unitless | 12 months |
|
|
|
| 0 |
| 23 |
| 2 |
| 23 |
| 7 |
| 23 |
| EG001 | Placebo Pill | placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects | 0 | 19 | 0 | 19 | 6 | 19 |
| Motor vehicle trauma | Surgical and medical procedures | Non-systematic Assessment |
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| Right ankle trauma | Surgical and medical procedures | Non-systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
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| Fingers edema | General disorders | Non-systematic Assessment |
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| Trauma | General disorders | Non-systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| Fatigue | Hepatobiliary disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Muscle cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lipoma | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Shoulder arthroplasty | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Left total hip |
|