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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00440440
First Posted: February 27, 2007
Last Update Posted: August 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Diabetes Center of the Southwest
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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 ]

Secondary Outcome Measures:
  • Study the effect in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy on: [ Time Frame: 6 months ]
  • Mean absolute change in hepatic fat measured by NMR spectroscopy. [ Time Frame: 6 months ]
  • Mean absolute change in total and regional adipose tissue mass measured by DEXA [ Time Frame: 6 months ]
  • Mean absolute change in total and regional lean body mass measured by DEXA. [ Time Frame: 6 months ]
  • Mean absolute change in total body and regional (arm, leg, ribs) BMC and BMD [ Time Frame: 6 months ]
  • Mean absolute change in hip BMC and BMD (mean of two hips) [ Time Frame: 6 months ]
  • Mean absolute change in spine BMC and lumbar spine (L1-L4) BMD [ Time Frame: 6 months ]

Enrollment: 0
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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: sandeep dhindsa, Department of Endocrinology and Metabolism
ClinicalTrials.gov Identifier: NCT00440440     History of Changes
Other Study ID Numbers: GR-940
First Submitted: February 23, 2007
First Posted: February 27, 2007
Last Update Posted: August 10, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents