Metabolic SyndromePhase 4NCT00487734

Effect of Testosterone Replacement on Insulin Resistance

A Phase 4 study testing Testosterone gel in people with Metabolic Syndrome and Hypogonadism, run by McGuire Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to determine whether testosterone replacement improves insulin sensitivity in non-obese men with low testosterone and the metabolic syndrome. The metabolic syndrome includes three of the following five conditions, 1) an elevated blood pressure (greater than 130/85), 2) a triglyceride level greater than… Read more about this study

Who is it for?: Ages 20 to 65 years, men only
Conditions the study is for: Metabolic Syndrome, Hypogonadism
What is being tested?: Testosterone gel
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: 1 siteUnited States
Study dates: Aug 2007to Oct 2010
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 20 to 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Metabolic syndrome (have 3 out of the following 4 criteria):
BP > 130/85 or on antihypertensive therapy
Fasting glucose > 100 mg/dl
Fasting TG > 150 mg/dl or on a triglyceride lowering agent (fenofibrate, gemfibrozil, niacin in doses of >= 500 mg/day, or fish oils in doses of >=2000mg DHA+EPA)
Fasting HDL-C < 40 mg/dl Note that the waist circumference will not be used as one of the criteria for the metabolic syndrome for this study because we are studying non-obese subjects.
Total Testosterone less than 300 ng/dl

Who cannot join

Women.
Men less than 20 years of age.
BMI > or = to 30 kg/M2.
Use of testosterone preparations within 1 year of the screening visit
Use of hypoglycemic medications within the previous 3 months.
Fasting blood glucose > 126 mg/dl.

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The following men will be excluded because of the potential safety issues in the placebo treated group:
Creatinine greater than 1.4 mg/dl
Triglyceride levels greater than 500 mg/dl
HDL-C levels less than 20 mg/dl
Blood pressure greater than 160/90
The following men will be excluded because of the potential side effects of testosterone therapy:
Men greater than 65 years of age
International prostate symptom score >19
PSA greater than 2.5
History of benign prostatic hypertrophy
History of prostate cancer
Abnormal digital rectal exam
Hg greater than 16 mg/dl or Hct greater than 48%
peripheral edema

Trial locations and contacts

1 site in 1 country.

United States1 site

Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249

Other trials in United States

About this study

Official title: Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome

Read the detailed description

In this proposal, we will examine the relationship between hypogonadism and insulin sensitivity. The strongest relationship between hypogonadism and insulin resistance appears to reside in men with the metabolic syndrome who have a normal BMI. The causal relationship between these two conditions is unknown. Therefore, we propose to determine if testosterone replacement in hypogonadal non-obese men with metabolic syndrome will improve insulin sensitivity. Data obtained from this preliminary investigation, will hopefully result in a hypothesis that can be tested in a larger, more rigorous trial in the future.

Conditions: Metabolic Syndrome, Hypogonadism
Being tested: Testosterone gel, Placebo for testosterone gel
Keywords: Metabolic Syndrome, Hypogonadism, Insulin Resistance
Medical subject headings: Metabolic Syndrome, Hypogonadism, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Testosterone gelRadiation
Also called Androgel
testosterone gel, applied daily. Dosed to achieve testosterone level <500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.
Placebo for testosterone gelDrug
Placebo gel, 2.5g for each gel packet

Study groups in NCT00487734
Study group	Role	What they receive
1	Experimental	Subjects in this arm will receive testosterone gel Receives: Radiation: Testosterone gel
2	Placebo comparator	Not described Receives: Drug: Placebo for testosterone gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in insulin sensitivity as measured by HOMA-IR
Measured: 18 weeks

Secondary outcomes (3)

Changes in parameters of the Metabolic Syndrome
Measured: 18 weeks
Changes in body composition
Measured: 18 weeks
Changes in total and high MW adiponectin levels
Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Oct 2010

First posted19 Jun 2007 (estimated)
Study startAug 2007
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies 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, Investigator
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00487734
Sponsor's protocol ID: 01274
Status last verified: Oct 2012
First submitted: 15 Jun 2007
Last updated: 23 Oct 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome
ClinicalTrials.gov ID: NCT00487734
Acronym / sponsor ID: 01274
Conditions: Metabolic Syndrome, Hypogonadism
Keywords: Metabolic Syndrome, Hypogonadism, Insulin Resistance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: McGuire Research InstituteUniversity, hospital or other
Collaborators: Solvay Pharmaceuticals
Study start: Aug 2007
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 19 Jun 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Radiation: Testosterone gelSubjects in this arm will receive testosterone gel
2	Placebo comparator	Drug: Placebo for testosterone gel

Who may qualify

Ages: 20 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Metabolic syndrome (have 3 out of the following 4 criteria):
Total Testosterone less than 300 ng/dl

Key exclusion criteria (20 listed)

Women.
Men less than 20 years of age.
BMI > or = to 30 kg/M2.
Use of testosterone preparations within 1 year of the screening visit
Use of hypoglycemic medications within the previous 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, applied daily. Dosed to achieve testosterone level <500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.	Radiation	1
Placebo for testosterone gelPlacebo gel, 2.5g for each gel packet	Drug	2

Primary outcome

Change in insulin sensitivity as measured by HOMA-IR
Time frame: 18 weeks

3 secondary outcomes

Changes in parameters of the Metabolic Syndrome
Time frame: 18 weeks
Changes in body composition
Time frame: 18 weeks
Changes in total and high MW adiponectin levels
Time frame: 18 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
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Not yet recruitingPhase 2
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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.

Sonja K Fredrickson, MD principal investigator

Hunter Holmes McGuire VA Medical Center

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 Metabolic Syndrome and Hypogonadism, run by McGuire Research Institute 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 23 Oct 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in insulin sensitivity as measured by HOMA-IR (time frame: 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00487734.

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 23 Oct 2012.