Effect of Androgel on Type 2 Diabetic Males With Hypogonadism - Full Text View

Sponsor:	Kaleida Health
Collaborator:	Solvay Pharmaceuticals
Information provided by:	Kaleida Health
ClinicalTrials.gov Identifier:	NCT00350701

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

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 2010
Estimated Primary Completion Date:	June 2010 (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, 3 Gates Circle	Recruiting
Buffalo, New York, United States, 14209
Contact: Barbara Hall, LPN 716-887-5104 bhall@kaleidahealth.org
Contact: Lisa Martin, RN 716-887-4265 lmartin@kaleidahealth.org
Principal Investigator: Paresh Dandona

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, Kaleida Health
ClinicalTrials.gov Identifier:	NCT00350701 History of Changes
Other Study ID Numbers:	1911
Study First Received:	July 10, 2006
Last Updated:	June 24, 2010
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 February 09, 2012