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| ID | Type | Description | Link |
|---|---|---|---|
| 18379 | Other Identifier | IRB |
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| Name | Class |
|---|---|
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
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SPECIFIC AIMS
The primary purpose of this study is to determine whether treatment with pioglitazone can reduce serum levels of asymmetric dimethylarginine (ADMA) in patients with adult diabetes. Recent research has found that elevated serum ADMA is associated with increased cardiovascular events and mortality, particularly in people with diabetes (Boger 2005, Zoccali 2006, Ueda 2007). ADMA, by mediating nitric oxide (NO) availability, may trigger pro-atherogenic effects. High plasma concentration of this substance has been associated with intima-media thickening, left ventricular hypertrophy and all-cause and cardiovascular mortality in patients with end-stage renal disease, and associated with increased cardiovascular events in patients with diabetes (Kryzazanowska 2007). The result of higher levels of ADMA and reduced output of NO increases vasoconstriction, increases inflammation, and interferes with endothelial function. Preliminary studies indicate that pioglitazone may reduce ADMA levels, and thus lower cardiovascular risk.Thus, this protocol will test whether pioglitazone can reduce ADMA levels in adult patients with diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone then Placebo | Experimental | 18 volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take Pioglitazone for the first 12 week period of the study and then take the placebo for the final 12 weeks of the study. |
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| Placebo then Pioglitazone | Experimental | 18 (other half of participants) volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take the placebo for the first 12 week period of the study and then take the Pioglitazone for the final 12 weeks of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone then Placebo | Drug | Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Asymmetric Dimethylarginine (ADMA) Level | Labs measured micro moles per liter of ADMA levels in participants. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| NOx f2-isoprostanes | Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana E King, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Family Medicine, MUSC | Charleston | South Carolina | 29425 | United States |
After informed consent, a laboratory specimen will be obtained at the visit, including a pregnancy test (if indicated), and the screening ADMA level. This information will be used to determine study eligibility. Screened participants will be eligible if their ADMA > 0.50 μM/L. If not eligible would be excluded from study.
medical clinic, 36 participants recruited
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone | This is the analysis period during which participants took Pioglitazone. |
| FG001 | Placebo | The analysis period during which participant took the placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout Period of 4 Weeks |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone | This is the analysis period during which participants took Pioglitazone. |
| BG001 | Placebo | The analysis period during which participant took the placebo. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Asymmetric Dimethylarginine (ADMA) Level | Labs measured micro moles per liter of ADMA levels in participants. | Recruited 36 participants per randomization.1st analysis is serum Asymmetric Dimethylarginine ADMA at 12 weeks b/w groups. | Posted | Mean | 95% Confidence Interval | umol/L | 3 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 | This is the analysis period during which participants took Pioglitazone. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana King MD | Medical University of South Carolina | 843-792-8112 | kingde@musc.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System 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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|
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| Placebo then Pioglitazone | Drug | Subjects will take the placebo for the first 12 weeks of the study. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take the pioglitazone 30mg tablet daily for 3 months. |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | NOx f2-isoprostanes | Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress | 36 adults with diabetes enrolled in the study, and 31 completed the 7-month protocol. Adherence with medication was 93% during the trial according to pill counts at the final visit. Participants were allowed to take their other regular medications during the trial. | Posted | Mean | Standard Error | Oxidative stress | 3 months |
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| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo | The analysis period during which participant took the placebo. | 0 | 18 | 0 | 18 |
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |