ObesityPhase 1NCT01160328
Influence of Male Hormones on Regional Fat Metabolism
A Phase 1 study testing Leuprolide and Testosterone in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
The male sex hormone, testosterone, plays an important role in determining body fat distribution in men. This is especially evident in the dramatic shift in body composition as boys and girls reach sexual maturity. Normal weight women have twice the body fat of a normal weight man (30% vs. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Leuprolide and Testosterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jan 2013
- Phase
- Phase 1
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, weight stable individuals
- BMI 20-29 kg/m2
Who cannot join
- Smoking and tobacco use
- Diabetes and other disease
- Anti-depressants
Trial locations and contacts
1 site in 1 country.
About this study
The male sex hormone, testosterone, plays an important role in determining body fat distribution in men. This is especially evident in the dramatic shift in body composition as boys and girls reach sexual maturity. Normal weight women have twice the body fat of a normal weight man (30% vs. 15% on average) and men will have twice the stomach fat as women (10% vs. 5% of fat as intra-abdominal, men vs. women). These are likely sex-steroid linked events. Short and long term changes in regional fat distribution accompany testosterone deficiency and can be reversed by testosterone replacement. Testosterone deficient men have increased stomach fat that can be reversed with testosterone replacement therapy. Interestingly, the mechanism by which testosterone affects where we store fat is unknown. It is important to understand how testosterone influences where we store fat as it is well established that increased stomach fat results in elevated disease risk.
The proposed study aims to examine the effect of short term, temporary testosterone decreases on how and where men store fat. The investigators will compare fat storage between men given Lupron to temporarily decrease testosterone levels those that receive Lupron plus testosterone replacement vs. a no treatment control group. Comparing these three groups will allow us to understand the effects of testosterone on short-term changes in fat tissue function that lead to the long-term changes in where we store body fat.
Read the detailed description
There are 3 groups to which you might be assigned. Assignment to these groups is random (ie. by flip of a coin).
If you are assigned to…
- Group 1 - you will receive no treatments.
- Group 2 - you will be given an injection of leuprolide acetate (Lupron) which will temporarily lower sex hormones. This injection will be given two times during the 7 week treatment period.
- Group 3 - you will be given the injections of Lupron but after the second injection, you will also be required to apply a testosterone gel that will result in maintenance of your testosterone levels. The testosterone gel is rubbed on the upper shoulders, similar to putting on suntan lotion. You will be shown how to put this on.
If you are in group 2 or 3 you will be given testosterone gel, a male hormone, at the end of the study to help prevent symptoms such as hot flashes, until your body has time to return to its pre-study hormone levels. This can take up to 4 weeks.
In addition to the treatment period, you will also:
- If you are in group 1, have 4 fat biopsies that are like a miniature liposuction. The investigators numb the skin before doing the biopsies. If you are in group 2 or 3, you will also have 1 muscle biopsy at the end of the treatment period. In addition, if you are in group 2 or 3, you will also have a fat and muscle biopsy before you start the hormone treatment.
- All groups will need to spend two days and nights in the Clinical Research Unit of the Mayo Clinic and your meals will be provided by the for 5 days beforehand. You will also need to spend one morning undergoing some initial tests.
- You will have your body fat measured before and after the hormone treatment using x-ray like equipment that will expose you to some radiation.
- Our measures of fat metabolism use molecules that have a small amount of radioactivity.
Remuneration is provided.
- Conditions
- Obesity
- Being tested
- Leuprolide, Testosterone
- Keywords
- Regional Fat Storage, Fat Oxidation, Testosterone, Male
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprolideDrug
Also called Lupron
7.5 mg - 1 month depot, 2 doses over 7 weeks
TestosteroneDrug
Also called AndroGel
7.5g - 1% testosterone gel, daily x 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants in this group will not receive any treatment. |
| Lupron Group | Experimental | Participants in this group will receive leuprolide acetate (Lupron) treatment for 7 weeks resulting in temporary decreases in testosterone levels. Receives: Drug: Leuprolide |
| Lupron & Testosterone Group | Other | Participants in this group will receive 7 weeks of leuprolide acetate (Lupron) treatment with testosterone gel (Androgel). Receives: Drug: Leuprolide; Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Fat Metabolism
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Abbott
- Responsible party
- Principal investigator, Michael D. Jensen, Mayo Clinic
- Investigators
- Michael D Jensen, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160328
- Sponsor's protocol ID
- 09-000309
- Other IDs
- R01DK045343
- Status last verified
- May 2014
- First submitted
- 8 Jul 2010
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Male Hormones on Regional Fat Metabolism
- ClinicalTrials.gov ID
- NCT01160328
- Acronym / sponsor ID
- 09-000309
- Conditions
- Obesity
- Keywords
- Regional Fat Storage, Fat Oxidation, Testosterone, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Abbott
- Study start
- Jun 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Jul 2010 (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 male sex hormone, testosterone, plays an important role in determining body fat distribution in men. This is especially evident in the dramatic shift in body composition as boys and girls reach sexual maturity. Normal weight women have twice the body fat of a normal weight man (30% vs. 15% on average) and men will have twice the stomach fat as women (10% vs. 5% of fat as intra-abdominal, men vs. women). These are likely sex-steroid linked events. Short and long term changes in regional fat distribution accompany testosterone deficiency and can be reversed by testosterone replacement. Testosterone deficient men have increased stomach fat that can be reversed with testosterone replacement therapy. Interestingly, the mechanism by which testosterone affects where we store fat is unknown. It is important to understand how testosterone influences where we store fat as it is well established that increased stomach fat results in elevated disease risk.
The proposed study aims to examine the effect of short term, temporary testosterone decreases on how and where men store fat. The investigators will compare fat storage between men given Lupron to temporarily decrease testosterone levels those that receive Lupron plus testosterone replacement vs. a no treatment control group. Comparing these three groups will allow us to understand the effects of testosterone on short-term changes in fat tissue function that lead to the long-term changes in where we store body fat.
Detailed description
There are 3 groups to which you might be assigned. Assignment to these groups is random (ie. by flip of a coin).
If you are assigned to…
- Group 1 - you will receive no treatments.
- Group 2 - you will be given an injection of leuprolide acetate (Lupron) which will temporarily lower sex hormones. This injection will be given two times during the 7 week treatment period.
- Group 3 - you will be given the injections of Lupron but after the second injection, you will also be required to apply a testosterone gel that will result in maintenance of your testosterone levels. The testosterone gel is rubbed on the upper shoulders, similar to putting on suntan lotion. You will be shown how to put this on.
If you are in group 2 or 3 you will be given testosterone gel, a male hormone, at the end of the study to help prevent symptoms such as hot flashes, until your body has time to return to its pre-study hormone levels. This can take up to 4 weeks.
In addition to the treatment period, you will also:
- If you are in group 1, have 4 fat biopsies that are like a miniature liposuction. The investigators numb the skin before doing the biopsies. If you are in group 2 or 3, you will also have 1 muscle biopsy at the end of the treatment period. In addition, if you are in group 2 or 3, you will also have a fat and muscle biopsy before you start the hormone treatment.
- All groups will need to spend two days and nights in the Clinical Research Unit of the Mayo Clinic and your meals will be provided by the for 5 days beforehand. You will also need to spend one morning undergoing some initial tests.
- You will have your body fat measured before and after the hormone treatment using x-ray like equipment that will expose you to some radiation.
- Our measures of fat metabolism use molecules that have a small amount of radioactivity.
Remuneration is provided.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants in this group will not receive any treatment. |
| Lupron Group | Experimental | Drug: LeuprolideParticipants in this group will receive leuprolide acetate (Lupron) treatment for 7 weeks resulting in temporary decreases in testosterone levels. |
| Lupron & Testosterone Group | Other | Drug: Leuprolide, Drug: TestosteroneParticipants in this group will receive 7 weeks of leuprolide acetate (Lupron) treatment with testosterone gel (Androgel). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy, weight stable individuals
- BMI 20-29 kg/m2
Key exclusion criteria (3 listed)
- Smoking and tobacco use
- Diabetes and other disease
- Anti-depressants
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 |
|---|---|---|
| LeuprolideAlso: Lupron7.5 mg - 1 month depot, 2 doses over 7 weeks | Drug | Lupron & Testosterone Group, Lupron Group |
| TestosteroneAlso: AndroGel7.5g - 1% testosterone gel, daily x 7 weeks | Drug | Lupron & Testosterone Group |
Primary outcome
Regional Fat Metabolism
Time frame: 3 years
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 14 May 2014.
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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.
Michael D Jensen, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leuprolide and Testosterone in people with Obesity, run by Mayo Clinic 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 2 inclusion and 3 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 14 May 2014. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Regional Fat Metabolism (time frame: 3 years). 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 14 May 2014.