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Effect of Testosterone Gel Replacement on Fat Mass in Males With Low Testosterone Levels and Diabetes
This study is not yet open for participant recruitment.
Verified by Diabetes Center of the Southwest, May 2008
Sponsors and Collaborators: Diabetes Center of the Southwest
Solvay Pharmaceuticals
Information provided by: Diabetes Center of the Southwest
ClinicalTrials.gov Identifier: NCT00440440
  Purpose

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.


Condition Intervention Phase
Hypogonadism
Diabetes
Drug: Testosterone gel
Drug: placebo
Phase IV

MedlinePlus related topics: Diabetes
Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Effect of Androgel on Total and Regional Adipose Tissue and Lean Body Mass in Type 2 Diabetic Patients With Hypogonadism

Further study details as provided by Diabetes Center of the Southwest:

Primary Outcome Measures:
  • Mean absolute change in visceral adipose tissue mass in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Study the effect in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy on: [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean absolute change in hepatic fat measured by NMR spectroscopy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean absolute change in total and regional adipose tissue mass measured by DEXA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean absolute change in total and regional lean body mass measured by DEXA. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean absolute change in total body and regional (arm, leg, ribs) BMC and BMD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean absolute change in hip BMC and BMD (mean of two hips) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean absolute change in spine BMC and lumbar spine (L1-L4) BMD [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: August 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
testosterone gel
Drug: Testosterone gel
Testosterone gel to be applied daily, starting does 5g.
2: Placebo Comparator
placebo gel
Drug: placebo
placebo gel apply daily

Detailed Description:

Hypogonadism is associated with increase in fat mass, decrease in muscle mass, accelerated bone loss, decreased libido and effects on mood. Androgen replacement in this context is clearly beneficial, and numerous studies have demonstrated improvements in bone and muscle mass, reductions in body fat and improvement in insulin sensitivity, libido and mood following treatment. Testosterone replacement leads to a dose-dependent decrease in adipose tissue and increase in muscle mass and strength. The principal focus of the proposed research is to evaluate the effect of androgel on lean body mass and regional adipose tissue mass (including hepatic and visceral fat) in type 2 diabetic patients with hypogonadism, a population that is likely to benefit from a reduction in adipose tissue and an increase in muscle mass.

  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: 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.

Exclusion Criteria:

  • 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.
  • The subject has systolic blood pressure >170mmHg or diastolic blood pressure >100 mmHg while on or off anti-hypertensive treatment.
  • Generalized skin disease that could affect the absorption of testosterone gel (ie, psoriasis);
  • Morning prolactin level greater than 40 mg/mL
  • Subjects with serum fasting triglyceride concentration > 500 mg/dL at screening or with history of hypertriglyceridemia-induced pancreatitis.
  • Participation in any other concurrent clinical trial
  • Any other life-threatening, non-cardiac disease
  • Use of an investigational agent or therapeutic regimen within 30 days or 5 half-lives (which ever is longer) preceding the first dose of study medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440440

Contacts
Contact: Sandeep Dhindsa, MBBS 432-686-0000 sandhindsa@yahoo.com

Locations
United States, Texas
Diabetes Center of the Southwest
Midland, Texas, United States, 79707
Sponsors and Collaborators
Diabetes Center of the Southwest
Solvay Pharmaceuticals
Investigators
Principal Investigator: Sandeep Dhindsa, MBBS Diabetes Center of the Southwest
  More Information

Responsible Party: Department of Endocrinology and Metabolism ( sandeep dhindsa )
Study ID Numbers: GR-940
Study First Received: February 23, 2007
Last Updated: May 8, 2008
ClinicalTrials.gov Identifier: NCT00440440  
Health Authority: United States: Institutional Review Board

Keywords provided by Diabetes Center of the Southwest:
hypogonadism
diabetes
visceral fat
hepatic fat
lean mass

Study placed in the following topic categories:
Testosterone
Metabolic Diseases
Hypogonadism
Gonadal Disorders
Diabetes Mellitus
Endocrine System Diseases
Methyltestosterone
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:
Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 14, 2009