HealthyNCT03289559
Effects of Testosterone and Fat Utilization
A study testing GnRH antagonist, Aromatase Inhibitors and Testosterone gel in people with Healthy and Volunteers, run by University of Colorado, Denver.
Trial summary
Evidence is accumulating that there are sex differences in energy and substrate metabolism. The positive or negative consequences of such metabolic differences between men and women need to be evaluated with respect to health outcomes. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Volunteers
- What is being tested?
- GnRH antagonist, Aromatase Inhibitors and Testosterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 1 Jan 2014
- Phase
- Interventional
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal weight (BMI of 23-29.9 kg/m2)
- not be highly trained (< 5hrs of moderate intensity, planned exercise per week).
Who cannot join
- Patients will be excluded if they have one or more of the following out-of-range values measured on a fasting blood sample:
- glucose <65 or > 110 mg/dl,
- insulin > 20 uU/ml,
- thyroid stimulating hormone <0.5 or >5.0 uU/ml,
- growth hormone >2.5 ng/ml.
- Subjects who may be:
Show all 12Show fewer
- anemic (hemoglobin < 14.5 g/dl men ),
- have abnormal liver function tests:
- alanine amino transferase > 47 U/l,
- aspartate aminotransferase, > 47 U/l,
- alkaline phosphatase <39 or >117 U/l) or
- creatinine (<0.6 or >1.1 mg/dl).
About this study
Official title: Testosterone Effects on Systemic Lipolysis and Whole Body Lipid Utilization
Evidence is accumulating that there are sex differences in energy and substrate metabolism. The positive or negative consequences of such metabolic differences between men and women need to be evaluated with respect to health outcomes. The importance of aberrant lipid metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes understanding the distinction between "normal" vs aberrant critical to future treatment and prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism and substrate oxidation in non-obese, healthy individuals, have been consistently observed. In addition, distinct differences in men and women exist in the distribution of body fat, with men typically having greater central adiposity than women. Accumulation of fat in the abdomen is associated with an increased risk for metabolic abnormalities such as hyperlipidemia and insulin resistance. In the current study, therefore, the role of testosterone in determining the sex differences in catecholamine mediated substrate metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots will be addressed.
- Conditions
- Healthy, Volunteers
- Being tested
- GnRH antagonist, Aromatase Inhibitors, Testosterone gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH antagonistDrug
Aromatase InhibitorsDrug
Testosterone gelDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| GnRH antagonist + Placebo Gel | Placebo comparator | Not described Receives: Drug: GnRH antagonist; Drug: Aromatase Inhibitors |
| GnRH antagonist + Testosterone Gel | Active comparator | Not described Receives: Drug: GnRH antagonist; Drug: Aromatase Inhibitors; Drug: Testosterone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary fat tracer for storage of meal derived fatty acids
50 uCi of [1-14C] oleic acid administered with an inpatient test meal
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start1 Jan 2006
- Primary completion1 Jan 2011
- Study completion1 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Bessesen, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289559
- Sponsor's protocol ID
- 06-0010
- Status last verified
- Sep 2017
- First submitted
- 18 Sep 2017
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rynders CA, Schmidt SL, Bergouignan A, Horton TJ, Bessesen DH. Effects of short-term sex steroid suppression on dietary fat storage patterns in healthy males. Physiol Rep. 2018 Jan;6(2):e13533. doi: 10.14814/phy2.13533.
PubMed 29380951
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Effects on Systemic Lipolysis and Whole Body Lipid Utilization
- ClinicalTrials.gov ID
- NCT03289559
- Acronym / sponsor ID
- 06-0010
- Conditions
- Healthy, Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 Jan 2011 (actual)
- Study completion
- 1 Jan 2014 (actual)
- First posted
- 21 Sep 2017 (actual)
- 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.
Evidence is accumulating that there are sex differences in energy and substrate metabolism. The positive or negative consequences of such metabolic differences between men and women need to be evaluated with respect to health outcomes. The importance of aberrant lipid metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes understanding the distinction between "normal" vs aberrant critical to future treatment and prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism and substrate oxidation in non-obese, healthy individuals, have been consistently observed. In addition, distinct differences in men and women exist in the distribution of body fat, with men typically having greater central adiposity than women. Accumulation of fat in the abdomen is associated with an increased risk for metabolic abnormalities such as hyperlipidemia and insulin resistance. In the current study, therefore, the role of testosterone in determining the sex differences in catecholamine mediated substrate metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots will be addressed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| GnRH antagonist + Placebo Gel | Placebo comparator | Drug: GnRH antagonist, Drug: Aromatase Inhibitors |
| GnRH antagonist + Testosterone Gel | Active comparator | Drug: GnRH antagonist, Drug: Aromatase Inhibitors, Drug: Testosterone gel |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- normal weight (BMI of 23-29.9 kg/m2)
- not be highly trained (< 5hrs of moderate intensity, planned exercise per week).
Key exclusion criteria (12 listed)
- Patients will be excluded if they have one or more of the following out-of-range values measured on a fasting blood sample:
- glucose <65 or > 110 mg/dl,
- insulin > 20 uU/ml,
- thyroid stimulating hormone <0.5 or >5.0 uU/ml,
- growth hormone >2.5 ng/ml.
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 |
|---|---|---|
| GnRH antagonist | Drug | GnRH antagonist + Placebo Gel, GnRH antagonist + Testosterone Gel |
| Aromatase Inhibitors | Drug | GnRH antagonist + Placebo Gel, GnRH antagonist + Testosterone Gel |
| Testosterone gel | Drug | GnRH antagonist + Testosterone Gel |
Primary outcome
Dietary fat tracer for storage of meal derived fatty acids
Time frame: 4 weeks
50 uCi of [1-14C] oleic acid administered with an inpatient test meal
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 21 Sep 2017.
- Derived from this study: PubMed 29380951Rynders CA, Schmidt SL, Bergouignan A, Horton TJ, Bessesen DH. Effects of short-term sex steroid suppression on dietary fat storage patterns in healthy males. Physiol Rep. 2018 Jan;6(2):e13533. doi: 10.14814/phy2.13533.
- Individual participant dataSharing planned: No
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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.
Daniel Bessesen, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing GnRH antagonist, Aromatase Inhibitors and Testosterone gel in people with Healthy and Volunteers, run by University of Colorado, Denver.
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 12 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 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Dietary fat tracer for storage of meal derived fatty acids (time frame: 4 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 NCT03289559, which also lists 1 linked publication.
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 21 Sep 2017.