HypogonadismPhase 4NCT00440440
Effect of Testosterone Gel Replacement on Fat Mass in Males With Low Testosterone Levels and Diabetes
A Phase 4 study testing Testosterone gel in people with Hypogonadism and Diabetes, run by Diabetes Center of the Southwest at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years, men only
- Conditions the study is for
- Hypogonadism, Diabetes
- What is being tested?
- Testosterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes Center of the Southwest
Midland, Texas, 79707
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypogonadism, Diabetes
- Being tested
- Testosterone gel, placebo
- Keywords
- hypogonadism, diabetes, visceral fat, hepatic fat, lean mass
- Medical subject headings
- Hypogonadism, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gelDrug
Also called Androgel
Testosterone gel to be applied daily, starting does 5g.
placeboDrug
placebo gel apply daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | testosterone gel Receives: Drug: Testosterone gel |
| 2 | Placebo comparator | placebo gel Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute change in visceral adipose tissue mass in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy.
Measured: 6 months
Secondary outcomes (7)
Study the effect in type 2 diabetic subjects with hypogonadism after 6 months of androgel therapy on:
Measured: 6 months
Mean absolute change in hepatic fat measured by NMR spectroscopy.
Measured: 6 months
Mean absolute change in total and regional adipose tissue mass measured by DEXA
Measured: 6 months
Mean absolute change in total and regional lean body mass measured by DEXA.
Measured: 6 months
Mean absolute change in total body and regional (arm, leg, ribs) BMC and BMD
Measured: 6 months
Mean absolute change in hip BMC and BMD (mean of two hips)
Measured: 6 months
Mean absolute change in spine BMC and lumbar spine (L1-L4) BMD
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startAug 2009
- Primary completionNov 2011 (estimated)
- Study completionJul 2012 (estimated)
Why it stopped: study merged with another study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Center of the Southwest
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Sandeep Dhindsa, MBBS, Principal investigator, Diabetes Center of the Southwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440440
- Sponsor's protocol ID
- GR-940
- Status last verified
- Aug 2015
- First submitted
- 23 Feb 2007
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Androgel on Total and Regional Adipose Tissue and Lean Body Mass in Type 2 Diabetic Patients With Hypogonadism
- ClinicalTrials.gov ID
- NCT00440440
- Acronym / sponsor ID
- GR-940
- Conditions
- Hypogonadism, Diabetes
- Keywords
- hypogonadism, diabetes, visceral fat, hepatic fat, lean mass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study merged with another study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Diabetes Center of the SouthwestUniversity, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Aug 2009
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Testosterone geltestosterone gel |
| 2 | Placebo comparator | Drug: placeboplacebo gel |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone gelAlso: AndrogelTestosterone gel to be applied daily, starting does 5g. | Drug | 1 |
| placeboplacebo gel apply daily | Drug | 2 |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Dhindsa, MBBS principal investigator
Diabetes Center of the Southwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone gel in people with Hypogonadism and Diabetes, run by Diabetes Center of the Southwest at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.