Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

January 14, 2022 updated by: Paresh Dandona, University at Buffalo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14221
        • Diabetes-Endocrinology Center of Western NY, 115 flint road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
placebo
Experimental: androgel 5g
Drug: androgel
androgel 5g
Experimental: androgel 10g
Drug: androgel 10g
androgel 10g
Other Names:
  • androgel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo
Time Frame: 8 weeks
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
Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone
Time Frame: 8 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University at Buffalo

Collaborators

Solvay Pharmaceuticals

Investigators

  • Principal Investigator: Paresh Dandona, MD, Kaleida Health/Diabetes Endocrinology Center of WNY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 10, 2006

First Submitted That Met QC Criteria

July 10, 2006

First Posted (Estimate)

July 11, 2006

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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