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

August 6, 2015 updated by: Diabetes Center of the Southwest

Effect of Androgel on Total and Regional Adipose Tissue and Lean Body Mass in Type 2 Diabetic Patients With Hypogonadism

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Midland, Texas, United States, 79707
        • Diabetes Center of the Southwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1
testosterone gel
Drug: Testosterone gel
Testosterone gel to be applied daily, starting does 5g.
Other Names:
  • Androgel
Placebo Comparator: 2
placebo gel
Drug: placebo
placebo gel apply daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Study the effect in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy on:
Time Frame: 6 months
6 months
Mean absolute change in hepatic fat measured by NMR spectroscopy.
Time Frame: 6 months
6 months
Mean absolute change in total and regional adipose tissue mass measured by DEXA
Time Frame: 6 months
6 months
Mean absolute change in total and regional lean body mass measured by DEXA.
Time Frame: 6 months
6 months
Mean absolute change in total body and regional (arm, leg, ribs) BMC and BMD
Time Frame: 6 months
6 months
Mean absolute change in hip BMC and BMD (mean of two hips)
Time Frame: 6 months
6 months
Mean absolute change in spine BMC and lumbar spine (L1-L4) BMD
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Diabetes Center of the Southwest

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Solvay Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandeep Dhindsa, MBBS, Diabetes Center of the Southwest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GR-940

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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