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Trial registered on ANZCTR


Registration number
ACTRN12614000610639
Ethics application status
Approved
Date submitted
19/05/2014
Date registered
6/06/2014
Date last updated
28/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Recruitment of brown fat in overweight adult humans with high blood pressure
Scientific title
The effect of telmisartan treatment on brown adipose tissue (BAT) in overweight hypertensive humans
Secondary ID [1] 284624 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ROBIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 291937 0
Overweight 291938 0
Condition category
Condition code
Metabolic and Endocrine 292290 292290 0 0
Metabolic disorders
Cardiovascular 292391 292391 0 0
Hypertension
Diet and Nutrition 292392 292392 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: change from usual blood pressure medication to telmisartan 40-80 mg daily (therapeutic dosage) orally for 4 weeks. Adherence will be monitored by drug tablet return.
Intervention code [1] 289408 0
Treatment: Drugs
Comparator / control treatment
Arm 2 (active comparator): change from usual medication to candesartan 8-16 mg daily (therapeutic dosage) orally for 4 weeks. Adherence will be monitored by drug tablet return.

Arm 3 (control): continue usual blood pressure medication
Control group
Active

Outcomes
Primary outcome [1] 292156 0
Brown fat abundance and activity by Positron Emission Tomography (PET)/Computerised Tomography (CT)
Timepoint [1] 292156 0
Four weeks
Secondary outcome [1] 308320 0
Glucose tolerance by oral glucose tolerance test
Timepoint [1] 308320 0
Four weeks
Secondary outcome [2] 308321 0
Insulin sensitivity by oral glucose tolerance test
Timepoint [2] 308321 0
Four weeks
Secondary outcome [3] 308322 0
Body composition by dual energy X-ray absortiometry
Timepoint [3] 308322 0
Four weeks

Eligibility
Key inclusion criteria
1. BMI: 20-30 kg/m2
2. Disease status: uncomplicated hypertension on mono-therapy (ACE inhibitor or calcium channel blockers (CCB)) with stable blood pressure control for > 6 months.
3. Willingness to give written informed consent and willingness to participate to and comply with the study
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* BMI <20 or >30 Kg/m2.
* Age <18 or >45 years old.
* Pregnant or breast-feeding.
* History/laboratory (screening test) evidence of significant cardiovascular, endocrine, neoplastic, renal, hepatic or metabolic disorders, including hyperkalaeamia.
* On more than 1 anti-hypertensive medication.
* Known hypersensitivity to any angiotensin receptor blocker.
* Current diabetes medication therapy (however, patients with pre-diabetes or diet-controlled diabetes not on medication may participate)
* On therapies with possible effects on brown fat and or glycemia (e.g. beta-agonists (including inhaled formulations), beta-blockers, alpha-blockers, diuretics, glucocorticoids and/or hormone replacement).
* Unwillingness to undergo blood pressure monitoring during treatment phase.
* Claustrophobia.
* History of illicit drug or alcohol abuse within the last 5 years; current use of drugs (by history) or alcohol (CAGE score>3).
* Inability to provide written informed consent
* Current use of medications/dietary supplements/alternative therapies known to alter endocrine/metabolic function.
* Current use of antiplatelet or anticoagulants (if subjects decide to participate in optional tissue biopsies).
* Current smoker or user of tobacco products
* Current participation in weight loss programs (dietary, exercise or pharmacological) or more than 3 kg weight changes in last 6 months


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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation: The primary endpoint is the change in BAT volume and activity before and after telmisartan treatment. Based on known improvement in insulin sensitivity by ~20% (which we hypothesize to correlate with BAT recruitment), a sample size of 16 subjects per group (taken into account 20% drop out) has 80% power to detect a difference in BAT of 10%, as guided by a BAT prevalence of ~50% in overweight individuals.
Analysis plan: Changes in BAT and glucose metabolism before and after treatment will be analysed with treatment effect in mixed model analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/06/2014
Actual
7/07/2014
Date of last participant enrolment
Anticipated
1/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2471 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 8125 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 289251 0
Government body
Name [1] 289251 0
National Health and Medical Research Council
Country [1] 289251 0
Australia
Funding source category [2] 289252 0
Charities/Societies/Foundations
Name [2] 289252 0
Diabetes Australia
Country [2] 289252 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Garvan Institute of Medical Research
Address
384 Victoria Street, Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 287925 0
Hospital
Name [1] 287925 0
St Vincent's Hospital, Sydney
Address [1] 287925 0
380 Victoria Street, Darlinghurst, NSW 2010
Country [1] 287925 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291024 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 291024 0
Ethics committee country [1] 291024 0
Australia
Date submitted for ethics approval [1] 291024 0
31/03/2014
Approval date [1] 291024 0
13/05/2014
Ethics approval number [1] 291024 0
HREC/13/SVH/377

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

Contacts
Principal investigator
Name 48518 0
Dr Paul Lee
Address 48518 0
Garvan Institute of Medical Research
Clinical Diabetes and Metabolism
384 Victoria Street
Darlinghurst
NSW 2010
Country 48518 0
Australia
Phone 48518 0
+61 2 9295 8416
Fax 48518 0
+61 2 9295 8481
Email 48518 0
p.lee@garvan.org.au
Contact person for public queries
Name 48519 0
Paul Lee
Address 48519 0
Garvan Institute of Medical Research
Clinical Diabetes and Metabolism
384 Victoria Street
Darlinghurst
NSW 2010
Country 48519 0
Australia
Phone 48519 0
+61 2 9295 8416
Fax 48519 0
+61 2 9295 8481
Email 48519 0
p.lee@garvan.org.au
Contact person for scientific queries
Name 48520 0
Paul Lee
Address 48520 0
Garvan Institute of Medical Research
Clinical Diabetes and Metabolism
384 Victoria Street
Darlinghurst
NSW 2010
Country 48520 0
Australia
Phone 48520 0
+61 2 9295 8416
Fax 48520 0
+61 2 9295 8481
Email 48520 0
p.lee@garvan.org.au

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.