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Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00350701
Recruitment Status : Unknown
Verified December 2012 by Paresh Dandona, MD, Kaleida Health.
Recruitment status was:  Active, not recruiting
First Posted : July 11, 2006
Last Update Posted : December 18, 2012
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: androgel Drug: androgel 10g Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism
Study Start Date : July 2006
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: androgel 5g
androgel 5g
Drug: androgel
androgel 5g

Experimental: androgel 10g
androgel 10g
Drug: androgel 10g
androgel 10g
Other Name: androgel

Placebo Comparator: placebo
Drug: placebo

Primary Outcome Measures :
  1. To detect a difference in Nuclear Factor kB between AndroGel and placebo from baseline and at 8 weeks. [ Time Frame: 8 weeks ]
    measure effect of teststerone on inflammation

Secondary Outcome Measures :
  1. Comparison of relative change from baseline in inflammatory mediators and reactive oxygen species generation after either AndroGel or placebo at week 8. [ Time Frame: 8 weeks ]
    Measures inflammation change with testosterone

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00350701

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United States, New York
Diabetes-Endocrinology Center of Western NY, 115 flint road
Buffalo, New York, United States, 14221
Sponsors and Collaborators
Kaleida Health
Solvay Pharmaceuticals
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Principal Investigator: Paresh Dandona, MD Kaleida Health/Diabetes Endocrinology Center of WNY

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Responsible Party: Paresh Dandona, MD, MD, Kaleida Health Identifier: NCT00350701     History of Changes
Other Study ID Numbers: 1911
First Posted: July 11, 2006    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012
Keywords provided by Paresh Dandona, MD, Kaleida Health:
DM type 2
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Gonadal Disorders
Endocrine System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents