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Completed

NCT Number: NCT00350701

Effect of Androgel on 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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Gonadal Disorders Hypogonadism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Diabetes-Endocrinology Center of Western NY, 115 flint road

Buffalo, New York, 14221, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AndroGel

Drug

androgel 5g

androgel 10g

Drug

androgel 10g

Other names: androgel

Placebo

Drug

placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University at Buffalo

Other

Collaborators

  • Solvay Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2006
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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