Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000613707
Ethics application status
Approved
Date submitted
27/05/2013
Date registered
29/05/2013
Date last updated
2/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Testosterone Therapy Combined with Very Low Caloric Diet on Weight Loss and Weight Maintenance in Obese Men: A Randomized Controlled Trial
Scientific title
Effect of Testosterone Therapy Combined with Very Low Caloric Diet on Weight Loss and Weight Maintenance in Obese Men: A Randomized Controlled Trial
Secondary ID [1] 282578 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity

 289262 0
Low testosterone 289275 0
Condition category
Condition code
Metabolic and Endocrine 289589 289589 0 0
Other metabolic disorders
Diet and Nutrition 289590 289590 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
56 weeks Randomised, Placebo-controlled Trial of Testosterone Replacement Therapy in combination with a very low calorie diet

Intramuscular testosterone undecanote, 1000mg delivered IM at baseline, week 6, 16, 26, 36 and 46 by study investigators

Optifast very low calorie diet administered for the first 8 weeks concurrently with the injections, providing approx 600-700 calories per day. A serve of non-starchy vegetables is encouraged to assist with hunger. Study participants are reviewed every 2 weeks by the doctor when on the very low calorie diet to review compliance and any adverse effects from the diet. These visit take approx 30 minutes. After the very low calorie diet phase, subjects are seen every 10 weeks, these visits take 30 minutes. In addition, visits at baseline, week 10 and week 56 take 3 hours.


Intervention code [1] 287243 0
Treatment: Drugs
Intervention code [2] 287250 0
Lifestyle
Comparator / control treatment
Placebo is 4 mls of oily base, indistinguishable from testosterone undecanoate

All participants recieve the very low calorie diet
Control group
Placebo

Outcomes
Primary outcome [1] 289679 0
Weight loss using calibrated digital scales
Timepoint [1] 289679 0
56 weeks after randomisation
Primary outcome [2] 289691 0
Weight maintenance using calibrated digital scales
Timepoint [2] 289691 0
56 weeks after randomisation
Secondary outcome [1] 303003 0
Body composition by DEXA
Timepoint [1] 303003 0
Week 56
Secondary outcome [2] 303019 0
Visceral fat by single- slice CT scan at L4-5
Timepoint [2] 303019 0
Week 56
Secondary outcome [3] 303020 0
Muscle strength by handgrip dynamometer
Timepoint [3] 303020 0
Week 56
Secondary outcome [4] 303021 0
Gut hormones by serum assay
Timepoint [4] 303021 0
Week 56
Secondary outcome [5] 303022 0
Exercise level by accelerometer
Timepoint [5] 303022 0
Week 56
Secondary outcome [6] 303023 0
Hypogonadal symptoms by validated questionnaire (Aging males symptoms)
Timepoint [6] 303023 0
Week 56
Secondary outcome [7] 303024 0
Gene changes in fat by microarray / PCR
Timepoint [7] 303024 0
2 weeks

Eligibility
Key inclusion criteria
Male sex, age 18-75 years, BMI 30-60 kg/m2and testosterone <12nmol/L
Minimum age
18 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
established pituitary or testicular disorders, contraindications to testosterone therapy including androgen-dependent carcinoma of the prostate or of the male mammary gland, known malignancy, hypersensitivity to the active substance or to any of the excipients, polycythemia (haematocrit>55%), known liver tumour, significant benign prostate hypertrophy, prostate specific antigen (PSA) > 4ng/ml, uncontrolled hypertension (>160/90 mm Hg despite anti-hypertensive medication, uncontrolled untreated sleep apnoea, severe disturbance in renal function (estimated glomerular filtration rate <30 ml/min), uncontrolled epilepsy, migraine, or significant cardiac insufficiency (New York Heart Association performance status >2), coagulation disorders, current use of weight-altering medications (thiazolidinediones, systemic glucocorticoids, antipsychotics, topiramate), unstable thyroid dysfunction (stable = normal TFT on thyroxine dose >3/12), Cushing’s disease; past history of bariatric surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment via the study co-ordinators at the Repatriation hospital, Heidelberg, Victoria

Randomisation by Pharmacy Department. Vials will be coded and identifiable by number. Austin Helath Pharmacy, but not the researchers or study subjects involved in the trial will be aware of the code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study will be conducted as a double-blind, randomised design. A standard block randomisation procedure will be used to ensure that the final design is very close to, if not exactly, balanced. Men will be stratified according to BMI <=37 or >37 and age <=60y or >60y
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2013
Actual
15/02/2013
Date of last participant enrolment
Anticipated
Actual
8/09/2014
Date of last data collection
Anticipated
Actual
9/12/2015
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1057 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 1058 0
Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors
Funding source category [1] 287358 0
University
Name [1] 287358 0
University of Melbourne
Country [1] 287358 0
Australia
Funding source category [2] 287359 0
Commercial sector/Industry
Name [2] 287359 0
Bayer Pharmaceuticals
Country [2] 287359 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Department of Medicine, University of Melbourne, Austin Health, 145 Studley Rd, Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 286106 0
None
Name [1] 286106 0
Address [1] 286106 0
Country [1] 286106 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289335 0
Austin Health, Human Research Ethics Committee
Ethics committee address [1] 289335 0
Ethics committee country [1] 289335 0
Australia
Date submitted for ethics approval [1] 289335 0
Approval date [1] 289335 0
21/03/2013
Ethics approval number [1] 289335 0
H2012 / 04495, H2008 / 03330

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40358 0
A/Prof Mathis Grossmann
Address 40358 0
Department of Medicine, Austin Health, 145 Studley Road, Heidelberg, VIC 3084
Country 40358 0
Australia
Phone 40358 0
+61394965000
Fax 40358 0
Email 40358 0
[email protected]
Contact person for public queries
Name 40359 0
Mark Ng Tang Fui
Address 40359 0
Department of Endocrinology, Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 40359 0
Australia
Phone 40359 0
+61394962082
Fax 40359 0
Email 40359 0
[email protected]
Contact person for scientific queries
Name 40360 0
Mark Ng Tang Fui
Address 40360 0
Department of Endocrinology, Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 40360 0
Australia
Phone 40360 0
+61394962082
Fax 40360 0
Email 40360 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.