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Sponsors and Collaborators: |
Kaleida Health Solvay Pharmaceuticals |
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Information provided by: | Kaleida Health |
ClinicalTrials.gov Identifier: | NCT00350701 |
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus Type 2 |
Drug: Testosterone( AndroGel) |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism |
Estimated Enrollment: | 36 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | June 2008 |
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.
Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Diabetes-Endocrinology Center of Western NY, 3 Gates Circle | Recruiting |
Buffalo, New York, United States, 14209 | |
Contact: Barbara Hall, LPN 716-887-5104 bhall@kaleidahealth.org | |
Contact: Lisa Martin, RN 716-887-4265 lmartin@kaleidahealth.org | |
Principal Investigator: Paresh Dandona |
Principal Investigator: | Paresh Dandona, MD | Kaleida Health/Diabetes Endocrinology Center of WNY |
Study ID Numbers: | 1911 |
Study First Received: | July 10, 2006 |
Last Updated: | January 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00350701 |
Health Authority: | United States: Institutional Review Board |
DM type 2 Hypogonadism Testosterone AndroGel |
Metabolic Diseases Gonadal Disorders Diabetes Mellitus Stress Endocrine System Diseases Methyltestosterone Testosterone 17 beta-cypionate |
Testosterone Hypogonadism Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |