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

This study has been withdrawn prior to enrollment.
(study merged with another study)
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Diabetes Center of the Southwest
ClinicalTrials.gov Identifier:
NCT00440440
First received: February 23, 2007
Last updated: June 23, 2010
Last verified: June 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effect of Androgel on Total and Regional Adipose Tissue and Lean Body Mass in Type 2 Diabetic Patients With Hypogonadism

Resource links provided by NLM:


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 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
testosterone gel
Drug: Testosterone gel
Testosterone gel to be applied daily, starting does 5g.
Other Name: Androgel
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440440

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

No publications provided

Responsible Party: sandeep dhindsa, Department of Endocrinology and Metabolism
ClinicalTrials.gov Identifier: NCT00440440     History of Changes
Other Study ID Numbers: GR-940
Study First Received: February 23, 2007
Last Updated: June 23, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Hypogonadism
Endocrine System Diseases
Glucose Metabolism Disorders
Gonadal Disorders
Metabolic Diseases
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014