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Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Paresh Dandona, MD, Kaleida Health.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350701
First Posted: July 11, 2006
Last Update Posted: December 18, 2012
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.
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health
  Purpose
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.

Condition Intervention Phase
Diabetes Mellitus Type 2 Drug: androgel Drug: androgel 10g Drug: placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Paresh Dandona, MD, Kaleida Health:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 36
Study Start Date: July 2006
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo
Drug: placebo
placebo

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00350701


Locations
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
Investigators
Principal Investigator: Paresh Dandona, MD Kaleida Health/Diabetes Endocrinology Center of WNY
  More Information

Responsible Party: Paresh Dandona, MD, MD, Kaleida Health
ClinicalTrials.gov Identifier: NCT00350701     History of Changes
Other Study ID Numbers: 1911
First Submitted: July 10, 2006
First Posted: July 11, 2006
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Paresh Dandona, MD, Kaleida Health:
DM type 2
Hypogonadism
Testosterone
AndroGel

Additional relevant MeSH terms:
Diabetes Mellitus
Hypogonadism
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gonadal Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents