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

Phase 2

Recruiting

• Conditions: Hypertension; Overweight; Metabolic and Endocrine - Metabolic disorders; Cardiovascular - Hypertension; Diet and Nutrition - Obesity

• Registration Number: ACTRN12614000610639
• Lead Sponsor: Garvan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brown fat abundance and activity by Positron Emission Tomography (PET)/Computerised Tomography (CT)[Four weeks]

Secondary Outcome Measures

Name	Time	Method
Glucose tolerance by oral glucose tolerance test[Four weeks];Insulin sensitivity by oral glucose tolerance test[Four weeks];Body composition by dual energy X-ray absortiometry [Four weeks]