Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
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|ClinicalTrials.gov Identifier: NCT00350701|
Recruitment Status : Unknown
Verified December 2012 by Paresh Dandona, MD, Kaleida Health.
Recruitment status was: Active, not recruiting
First Posted : July 11, 2006
Last Update Posted : December 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type 2||Drug: androgel Drug: androgel 10g Drug: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism|
|Study Start Date :||July 2006|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||July 2013|
Experimental: androgel 5g
Experimental: androgel 10g
Drug: androgel 10g
Other Name: androgel
Placebo Comparator: placebo
- To detect a difference in Nuclear Factor kB between AndroGel and placebo from baseline and at 8 weeks. [ Time Frame: 8 weeks ]measure effect of teststerone on inflammation
- Comparison of relative change from baseline in inflammatory mediators and reactive oxygen species generation after either AndroGel or placebo at week 8. [ Time Frame: 8 weeks ]Measures inflammation change with testosterone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350701
|United States, New York|
|Diabetes-Endocrinology Center of Western NY, 115 flint road|
|Buffalo, New York, United States, 14221|
|Principal Investigator:||Paresh Dandona, MD||Kaleida Health/Diabetes Endocrinology Center of WNY|