Back to resultsEffect of Androgel on Type 2 Diabetic Males With Hypogonadism
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
androgel
androgel 10g
placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus Type 2 focused on measuring DM type 2, Hypogonadism, Testosterone, AndroGel
Eligibility Criteria
Inclusion Criteria: Males with age 35-75 years inclusive. Evidence of hypogonadism: low free testosterone. Type 2 Diabetes People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed. If currently on testosterone replacement,testosterone treatment will be held for 8 weeks. BP under control even if on medication. Exclusion Criteria: Coronary event or procedure in previous past 4 wks. High PSA H/O prostate cancer Hepatic or renal disease Participation in any other concurrent clinical trial Any other life- threatening , non cardiac disease. Uncontrolled BP Congestive heart failure High hemoglobin Use of investigational agent or therapeutic regimen within 30 days of study.
Sites / Locations
- Diabetes-Endocrinology Center of Western NY, 115 flint road
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
androgel 5g
androgel 10g
placebo
Arm Description
androgel 5g
androgel 10g
placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT00350701
First Posted
July 10, 2006
Last Updated
January 14, 2022
Sponsor
University at Buffalo
Collaborators
Solvay Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00350701
Brief Title
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
Official Title
Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
Solvay Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
DM type 2, Hypogonadism, Testosterone, AndroGel
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
androgel 5g
Arm Type
Experimental
Arm Description
androgel 5g
Arm Title
androgel 10g
Arm Type
Experimental
Arm Description
androgel 10g
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
androgel
Intervention Description
androgel 5g
Intervention Type
Drug
Intervention Name(s)
androgel 10g
Other Intervention Name(s)
androgel
Intervention Description
androgel 10g
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo
Description
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
Time Frame
8 weeks
Title
Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone
Description
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.
Time Frame
8 week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males with age 35-75 years inclusive.
Evidence of hypogonadism: low free testosterone.
Type 2 Diabetes
People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.
If currently on testosterone replacement,testosterone treatment will be held for 8 weeks.
BP under control even if on medication.
Exclusion Criteria:
Coronary event or procedure in previous past 4 wks.
High PSA
H/O prostate cancer
Hepatic or renal disease
Participation in any other concurrent clinical trial
Any other life- threatening , non cardiac disease.
Uncontrolled BP
Congestive heart failure
High hemoglobin
Use of investigational agent or therapeutic regimen within 30 days of study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paresh Dandona, MD
Organizational Affiliation
Kaleida Health/Diabetes Endocrinology Center of WNY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes-Endocrinology Center of Western NY, 115 flint road
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
12. IPD Sharing Statement
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Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
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