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Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health
ClinicalTrials.gov Identifier:
NCT00350701
First received: July 10, 2006
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Other Name: androgel
Experimental: androgel 10g
androgel 10g
 Drug: androgel 10g
androgel 10g
Other Name: androgel
Placebo Comparator: placebo
placebo
 Drug: placebo
placebo
Other Name: 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

Ages Eligible for Study:   35 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Paresh Dandona, MD, MD, Kaleida Health
ClinicalTrials.gov Identifier: NCT00350701     History of Changes
Other Study ID Numbers: 1911
Study First Received: July 10, 2006
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Kaleida Health:
DM type 2
Hypogonadism
Testosterone
AndroGel

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

ClinicalTrials.gov processed this record on May 16, 2013