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Clinical Trial Details

Recruitment of brown fat in overweight adult humans with high blood pressure

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Trial Information

Broad Health Condition Metabolic and Endocrine
Cardiovascular
Diet and Nutrition

Specific Health ConditionMetabolic disorders
Hypertension
Obesity

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst


Postcode
2010 - Darlinghurst

Anticipated date of first participant enrolment16/06/2014

Anticipated date of last participant enrolment16/06/2014

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

The primary aim of the study is to investigate the impact of telmisartan treatment on brown fat in humans. The hypothesis is that telmisartan recruits brown fat in humans, thereby improving glucose metabolism.
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 age18 Years

Maximum age45 Years

GenderBoth 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 

Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Garvan Institute of Medical Research
Primary Sponsor Address: 384 Victoria Street, Darlinghurst, NSW 2010
Primary Sponsor Country: Australia

Trial IDACTRN12614000610639

Contact person for information and recruitmentDr
Paul Lee
Garvan Institute of Medical Research Clinical Diabetes and Metabolism 384 Victoria Street Darlinghurst NSW 2010
+61 2 9295 8416
+61 2 9295 8481
Further information iconp.lee@garvan.org.au
Australia