ObesityNCT00983554
Metabolic Effects of Steroids in Obese Men
A study testing Anastrazole, Testosterone and Dutasteride in people with Obesity and Insulin Resistance, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.
Trial summary
Subjects will be randomized into 4 study groups: 1. Placebo; 2. Anastrazole and Testosterone; 3. Dutasteride and Testosterone; and 4. Testosterone only. A 2 step euglycemic clamp, body composition by dual X-ray absorptiometry scan, hormone and lipid assays will be performed to monitor metabolic effects of each… Read more about this study
- Who is it for?
- Ages 24 to 51 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Anastrazole, Testosterone and Dutasteride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2005to Oct 2009
- 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 24 to 51 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- free T level in the lower 25% of the normal range or below
- BMI ≥30kg/m2
- waist circumference ≥100cm
Who cannot join
- pituitary tumors
- HIV infection
- Klinefelter's syndrome
- Kallman's syndrome
- uncontrolled hypertension
- diabetes
Show all 15Show fewer
- congestive heart failure
- chronic lung disease
- acute coronary syndrome
- PSA >4µg/L
- aspartate aminotransferase (AST)> 3x upper limit of normal
- use of medications that might affect weight loss, muscle or bone metabolism or androgen metabolism, action or clearance.
- involvement in daily resistance training or high endurance exercise
- alcohol or drug dependence
- obstructive sleep apnea
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Diego
San Diego, California, 92103
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men
Subjects will be randomized into 4 study groups: 1. Placebo; 2. Anastrazole and Testosterone; 3. Dutasteride and Testosterone; and 4. Testosterone only. A 2 step euglycemic clamp, body composition by dual X-ray absorptiometry scan, hormone and lipid assays will be performed to monitor metabolic effects of each treatment group. We hypothesize that increasing testosterone levels would increase lean mass, decrease fat mass and improve insulin sensitivity. We further hypothesize that improvements in the metabolic profile would decrease with anastrazole and improve with dutasteride, given in conjunction with T administration.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Anastrazole, Testosterone, Dutasteride, GnRH antagonist
- Keywords
- testosterone, insulin, obesity, aromatase, 5 alpha reductase
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrazoleDrug
Arimidex 1mg daily
TestosteroneDrug
Testim 10g daily
DutasterideDrug
Avodart 2.5mg daily
GnRH antagonistDrug
Acyline 300 µg/kg subcutaneous injections every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Not described |
| Anastrazole and Testosterone | Experimental | Not described Receives: Drug: Anastrazole; Drug: Testosterone; Drug: Dutasteride; Drug: GnRH antagonist |
| Dutasteride and Testosterone | Experimental | Not described Receives: Drug: Testosterone; Drug: Dutasteride; Drug: GnRH antagonist |
| Testosterone | Experimental | Not described Receives: Drug: Testosterone; Drug: Dutasteride; Drug: GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
Measured: 14 weeks
Secondary outcomes (2)
body composition
Measured: 14 weeks
lipid profile
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startJun 2005
- Primary completionMay 2009
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of California, San Diego
- Investigators
- Karen L Herbst, PhD, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983554
- Sponsor's protocol ID
- DK65038 (completed)
- Status last verified
- Mar 2011
- First submitted
- 22 Sep 2009
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marin P, Holmang S, Gustafsson C, Jonsson L, Kvist H, Elander A, Eldh J, Sjostrom L, Holm G, Bjorntorp P. Androgen treatment of abdominally obese men. Obes Res. 1993 Jul;1(4):245-51. doi: 10.1002/j.1550-8528.1993.tb00618.x.
PubMed 16350577Marin P, Holmang S, Jonsson L, Sjostrom L, Kvist H, Holm G, Lindstedt G, Bjorntorp P. The effects of testosterone treatment on body composition and metabolism in middle-aged obese men. Int J Obes Relat Metab Disord. 1992 Dec;16(12):991-7.
PubMed 1335979DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
PubMed 382871Kapoor D, Goodwin E, Channer KS, Jones TH. Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes. Eur J Endocrinol. 2006 Jun;154(6):899-906. doi: 10.1530/eje.1.02166.
PubMed 16728551
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men
- ClinicalTrials.gov ID
- NCT00983554
- Acronym / sponsor ID
- DK65038 (completed)
- Conditions
- Obesity, Insulin Resistance
- Keywords
- testosterone, insulin, obesity, aromatase, 5 alpha reductase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of California, San Diego
- Study start
- Jun 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Oct 2009 (estimated)
- First posted
- 24 Sep 2009 (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.
Subjects will be randomized into 4 study groups: 1. Placebo; 2. Anastrazole and Testosterone; 3. Dutasteride and Testosterone; and 4. Testosterone only. A 2 step euglycemic clamp, body composition by dual X-ray absorptiometry scan, hormone and lipid assays will be performed to monitor metabolic effects of each treatment group. We hypothesize that increasing testosterone levels would increase lean mass, decrease fat mass and improve insulin sensitivity. We further hypothesize that improvements in the metabolic profile would decrease with anastrazole and improve with dutasteride, given in conjunction with T administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | – |
| Anastrazole and Testosterone | Experimental | Drug: Anastrazole, Drug: Testosterone, Drug: Dutasteride, Drug: GnRH antagonist |
| Dutasteride and Testosterone | Experimental | Drug: Testosterone, Drug: Dutasteride, Drug: GnRH antagonist |
| Testosterone | Experimental | Drug: Testosterone, Drug: Dutasteride, Drug: GnRH antagonist |
Who may qualify
- Ages
- 24 to 51 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- free T level in the lower 25% of the normal range or below
- BMI ≥30kg/m2
- waist circumference ≥100cm
Key exclusion criteria (15 listed)
- pituitary tumors
- HIV infection
- Klinefelter's syndrome
- Kallman's syndrome
- uncontrolled hypertension
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 |
|---|---|---|
| AnastrazoleArimidex 1mg daily | Drug | Anastrazole and Testosterone |
| TestosteroneTestim 10g daily | Drug | Anastrazole and Testosterone, Dutasteride and Testosterone, Testosterone |
| DutasterideAvodart 2.5mg daily | Drug | Anastrazole and Testosterone, Dutasteride and Testosterone, Testosterone |
| GnRH antagonistAcyline 300 µg/kg subcutaneous injections every 2 weeks | Drug | Anastrazole and Testosterone, Dutasteride and Testosterone, Testosterone |
Primary outcome
insulin sensitivity
Time frame: 14 weeks
2 secondary outcomes
body composition
Time frame: 14 weeks
lipid profile
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
- Background: PubMed 16350577Marin P, Holmang S, Gustafsson C, Jonsson L, Kvist H, Elander A, Eldh J, Sjostrom L, Holm G, Bjorntorp P. Androgen treatment of abdominally obese men. Obes Res. 1993 Jul;1(4):245-51. doi: 10.1002/j.1550-8528.1993.tb00618.x.
- Background: PubMed 1335979Marin P, Holmang S, Jonsson L, Sjostrom L, Kvist H, Holm G, Lindstedt G, Bjorntorp P. The effects of testosterone treatment on body composition and metabolism in middle-aged obese men. Int J Obes Relat Metab Disord. 1992 Dec;16(12):991-7.
- Background: PubMed 382871DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
- Background: PubMed 16728551Kapoor D, Goodwin E, Channer KS, Jones TH. Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes. Eur J Endocrinol. 2006 Jun;154(6):899-906. doi: 10.1530/eje.1.02166.
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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.
Karen L Herbst, PhD, MD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anastrazole, Testosterone and Dutasteride in people with Obesity and Insulin Resistance, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites 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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
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?
insulin sensitivity (time frame: 14 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 NCT00983554, which also lists 4 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 16 Mar 2011.