Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

University at Buffalo

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: androgel 10g; Drug: placebo; Drug: androgel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00350701

1911

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: Male

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 3 patient groups, including a placebo group

androgel 5g

Experimental group

Description:

androgel 5g

Treatment:

Drug: androgel

androgel 10g

Experimental group

Description:

androgel 10g

Treatment:

Drug: androgel 10g

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo