Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

NCT00350701 | Completed Phase 4 Results

• 1 other identifier: 1911
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus Type 2

Keywords

DM type 2; Hypogonadism; Testosterone; AndroGel

Outcome Measures

Primary Outcomes (1)

• Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo

  To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups

  8 weeks

Secondary Outcomes (2)

• Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo

  8 weeks

• Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone

  8 week

Study Arms (3)

androgel 5g

EXPERIMENTAL

androgel 5g

Drug: androgel

androgel 10g

EXPERIMENTAL

androgel 10g

Drug: androgel 10g

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

androgel DRUG

androgel 5g

androgel 5g

androgel 10g DRUG

androgel 10g

Also known as: androgel

androgel 10g

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University at Buffalo: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (1)

Diabetes-Endocrinology Center of Western NY, 115 flint road

Buffalo, New York, 14221, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Paresh Dandona
• Organization: University at Buffalo

dandona@buffalo.edu

7165351850

Study Officials

• Paresh Dandona, MD

  Kaleida Health/Diabetes Endocrinology Center of WNY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 10, 2006
• First Posted: July 11, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 10, 2022
• Results First Posted: February 10, 2022

Record last verified: 2022-01

Locations

US (1)