Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350701
• Other study ID #: 1911
• Status: Completed
• Phase: Phase 4
• Start date: July 2006
• Est. completion date: July 2013

Study information

• Verified date: January 2022
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hypogonadism

Intervention

Drug:
• androgel
androgel 5g
• androgel 10g
androgel 10g
• placebo
placebo

Locations

Country	Name	City	State
United States	Diabetes-Endocrinology Center of Western NY, 115 flint road	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	8 weeks
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	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.	8 week