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| Name | Class |
|---|---|
| Solvay Pharmaceuticals | INDUSTRY |
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This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.
Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress. Hypogonadism( low testosterone) is also associated with increased levels of inflammatory mediators and atherosclerosis.
This project is about studying the effect of testosterone replacement on different inflammatory cells in blood and urine. It will also compare the dose dependent effect on inflammatory cells. This also involves comparing level of inflammation in hypogonadic diabetic males treated with testosterone with those not treated with any replacement therapy.
This study involves applying AndroGel for 8 wks and studying effects during this time and thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| androgel 5g | Experimental | androgel 5g |
|
| androgel 10g | Experimental | androgel 10g |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| androgel | Drug | androgel 5g |
| |
| androgel 10g |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo | To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo | Comparison of relative percent change from baseline at 8 weeks in reactive oxygen species generation (measured as arbitrary units normalized to 100% at baseline) in mononuclear cells after either AndroGel or placebo using chemiluminescence PMSF activation assay. Values at 8 weeks are converted to percentage of the baseline and compared between the groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paresh Dandona, MD | Kaleida Health/Diabetes Endocrinology Center of WNY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes-Endocrinology Center of Western NY, 115 flint road | Buffalo | New York | 14221 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Androgel 5g | androgel 5g androgel: androgel 5g |
| FG001 | Androgel 10g | androgel 10g androgel 10g: androgel 10g |
| FG002 | Placebo | placebo placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Androgel 5g | androgel 5g androgel: androgel 5g |
| BG001 | Androgel 10g | androgel 10g androgel 10g: androgel 10g |
| 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 | Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo | To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups | Posted | Mean | Standard Deviation | Percent change from baseline | 8 weeks |
|
8 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 | Androgel 5g | androgel 5g androgel: androgel 5g | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paresh Dandona | University at Buffalo | 7165351850 | dandona@buffalo.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
androgel 10g |
|
|
| placebo | Drug | placebo |
|
| 8 weeks |
| Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone | To measure the relative percent change from baseline in the inflammatory mediator (CRP) at 8 weeks (values in ng/ml normalized to100% at baseline) following treatment with androgel compared to placebo. Values (in ng/ml) are converted to percentage of baseline at 8 weeks. | 8 week |
| BG002 |
| Placebo |
placebo placebo: placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Placebo |
placebo placebo: placebo |
|
|
| Secondary | Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo | Comparison of relative percent change from baseline at 8 weeks in reactive oxygen species generation (measured as arbitrary units normalized to 100% at baseline) in mononuclear cells after either AndroGel or placebo using chemiluminescence PMSF activation assay. Values at 8 weeks are converted to percentage of the baseline and compared between the groups | Posted | Mean | Standard Deviation | percentage of baseline value | 8 weeks |
|
|
|
| Secondary | Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone | To measure the relative percent change from baseline in the inflammatory mediator (CRP) at 8 weeks (values in ng/ml normalized to100% at baseline) following treatment with androgel compared to placebo. Values (in ng/ml) are converted to percentage of baseline at 8 weeks. | Posted | Mean | Standard Deviation | percentage of baseline value | 8 week |
|
|
|
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Androgel 10g | androgel 10g androgel 10g: androgel 10g | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Placebo | placebo placebo: placebo | 0 | 15 | 0 | 15 | 0 | 15 |
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| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
|
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