Obesity in MenPhase 2NCT01616732
Testosterone and Weight Loss
A Phase 2 study testing Testosterone in people with Obesity in Men, run by Austin Health at 1 site in Australia.
Trial summary
The investigators hypothesise that testosterone therapy will synergize with dietary intervention to achieve weight loss. Obese men will receive diet, and be randomised to either testosterone therapy or placebo. Primary outcomes will be weight and body composition. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Obesity in Men
- What is being tested?
- Testosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2013to Dec 2015
- Phase
- Phase 2
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >30
Who cannot join
- contraindications to testosterone therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Testosterone and Diet on Weight
The investigators hypothesise that testosterone therapy will synergize with dietary intervention to achieve weight loss. Obese men will receive diet, and be randomised to either testosterone therapy or placebo. Primary outcomes will be weight and body composition.
- Conditions
- Obesity in Men
- Being tested
- Testosterone, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
TU im
placeboDrug
placebo im
| Study group | Role | What they receive |
|---|---|---|
| testosterone | Active comparator | against placebo Receives: Drug: Testosterone |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity in MenStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mathis Grossmann, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616732
- Sponsor's protocol ID
- 04495
- Status last verified
- Jun 2016
- First submitted
- 8 Jun 2012
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Grossmann M, Fui MNT, Nie T, Hoermann R, Clarke MV, Cheung AS, Zajac JD, Davey RA. Changes in white adipose tissue gene expression in a randomized control trial of dieting obese men with lowered serum testosterone alone or in combination with testosterone treatment. Endocrine. 2021 Aug;73(2):463-471. doi: 10.1007/s12020-021-02722-0. Epub 2021 Apr 17.
PubMed 33864607Ng Tang Fui M, Prendergast LA, Dupuis P, Raval M, Strauss BJ, Zajac JD, Grossmann M. Effects of testosterone treatment on body fat and lean mass in obese men on a hypocaloric diet: a randomised controlled trial. BMC Med. 2016 Oct 7;14(1):153. doi: 10.1186/s12916-016-0700-9.
PubMed 27716209
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Testosterone and Diet on Weight
- ClinicalTrials.gov ID
- NCT01616732
- Acronym / sponsor ID
- 04495
- Conditions
- Obesity in Men
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Austin HealthOther government
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Jun 2012 (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 investigators hypothesise that testosterone therapy will synergize with dietary intervention to achieve weight loss. Obese men will receive diet, and be randomised to either testosterone therapy or placebo. Primary outcomes will be weight and body composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| testosterone | Active comparator | Drug: Testosteroneagainst placebo |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI >30
Key exclusion criteria (1 listed)
- contraindications to testosterone therapy
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 |
|---|---|---|
| TestosteroneTU im | Drug | testosterone |
| placeboplacebo im | Drug | placebo |
Primary outcome
weight
Time frame: 12 months
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 6 Jun 2016.
- Derived from this study: PubMed 33864607Grossmann M, Fui MNT, Nie T, Hoermann R, Clarke MV, Cheung AS, Zajac JD, Davey RA. Changes in white adipose tissue gene expression in a randomized control trial of dieting obese men with lowered serum testosterone alone or in combination with testosterone treatment. Endocrine. 2021 Aug;73(2):463-471. doi: 10.1007/s12020-021-02722-0. Epub 2021 Apr 17.
- Derived from this study: PubMed 27716209Ng Tang Fui M, Prendergast LA, Dupuis P, Raval M, Strauss BJ, Zajac JD, Grossmann M. Effects of testosterone treatment on body fat and lean mass in obese men on a hypocaloric diet: a randomised controlled trial. BMC Med. 2016 Oct 7;14(1):153. doi: 10.1186/s12916-016-0700-9.
Related trials for Obesity in Men
Not yet recruiting
A Multicenter, Randomized Controlled Superiority Trial Comparing Robotic-Assisted Versus Expert Cognitive Fusion Prostate Biopsy in Obese Men
Prostate Biopsy
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Active, not recruitingPhase 1
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
Healthy, Obesity
Active, not recruiting
Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer
Prostate Cancer
Active, not recruitingPhase 1
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
Healhty, Overweight or Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone in people with Obesity in Men, run by Austin Health at 1 site in Australia.
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 1 inclusion and 1 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 6 Jun 2016. 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 Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
weight (time frame: 12 months). 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 NCT01616732, which also lists 2 linked publications.
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 6 Jun 2016.