Effect of Testosterone Gel Replacement on Fat Mass in Males With Low Testosterone Levels and Diabetes

NCT00440440 | Withdrawn Phase 4

• 1 other identifier: GR-940
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to find out the effect of replacing testosterone in the form of a gel (Androgel®) on the amount of fat mass in males with low testosterone and diabetes.

Conditions

Hypogonadism; Diabetes

Keywords

hypogonadism; diabetes; visceral fat; hepatic fat; lean mass

Outcome Measures

Primary Outcomes (1)

• Mean absolute change in visceral adipose tissue mass in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy.

  6 months

Secondary Outcomes (7)

• Study the effect in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy on:

  6 months

• Mean absolute change in hepatic fat measured by NMR spectroscopy.

  6 months

• Mean absolute change in total and regional adipose tissue mass measured by DEXA

  6 months

• Mean absolute change in total and regional lean body mass measured by DEXA.

  6 months

• Mean absolute change in total body and regional (arm, leg, ribs) BMC and BMD

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

testosterone gel

Drug: Testosterone gel

2

PLACEBO COMPARATOR

placebo gel

Drug: placebo

Interventions

Testosterone gel DRUG

Testosterone gel to be applied daily, starting does 5g.

Also known as: Androgel

1

placebo DRUG

placebo gel apply daily

2

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: Hypogonadism will be defined as low total testosterone (\<300 ng/dL) and low calculated free testosterone (below 6.5ng/dL; calculated using testosterone and SHBG). Testosterone levels will be measured between 8 and 10 am. Subjects who have normal total but low free testosterone levels (or vice versa) will be asked to come again after one week to have their testosterone levels re-measured. They will be included in the study in their free and total testosterone levels are low on re-measurement.
• Type 2 diabetes
• Hemoglobin A1c \<8.0 %
• Subjects on medications for diabetes will be allowed as long as they are on stable doses of these compounds for at least 6 weeks. The dose of thiazolidinediones will have to be stable for 3 months prior to the study. The dosage of diabetic medications will not be changed during the study.

You may not qualify if:

• Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
• Hepatic disease (transaminase \> 3 times normal)
• Renal impairment (serum creatinine \> 1.5)
• Chronic steroid therapy
• Use of testosterone or other androgens (such as DHEA) in the last 3 months
• Panhypopituitarism
• HIV or hepatitis C
• Subjects will be excluded from the study for history of prostate or breast cancer, gonadal endocrine disorders
• Current or recent history of major psychiatric illness, significant uncontrolled systemic illness
• Sleep apnea
• History of alcoholism or substance abuse within the past year
• History of taking other drugs that might interfere with the results of the study (ie, Lupron, finasteride, spironolactone, cimetidine, antiandrogens, estrogens, p450 enzyme inducers, barbiturates)
• Abnormal prostate evidenced by prostatic symptoms, prostatic masses or induration on rectal examination, elevated levels of prostate specific antigen (\>4 ng/mL; subjects with PSA levels between 2.5-4 ng/mL will be permitted if prostate biopsy is negative) or positive biopsy, a urine flow rate of less than 12 mL/s, or an International Prostate Symptom Score greater than 19
• Hematocrit greater than 50%
• Body weight \>300 lbs (this is the maximum weight that can be accommodated on DEXA or MRI machines.

Sponsors & Collaborators

• Diabetes Center of the Southwest: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (1)

Diabetes Center of the Southwest

Midland, Texas, 79707, United States

Location

MeSH Terms

Conditions

Hypogonadism; Diabetes Mellitus

Interventions

Testosterone

Condition Hierarchy (Ancestors)

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

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

Study Officials

• Sandeep Dhindsa, MBBS

  Diabetes Center of the Southwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: August 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: July 1, 2012
• Last Updated: August 10, 2015

Record last verified: 2015-08

Locations

US (1)