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Extrait
Background and study aims The use of HAART in human immunodeficiency virus (HIV) management may lead to the development of HIV-associated lipodystrophy syndrome (HALS), characterised by abnormal body fat distribution (fat gain on the abdomen and fat loss from the face, arms and legs), high plasma triglycerides, high blood pressure and blood vessel dysfunction. HALS increases the risk of premature heart disease. Up to 85% of patients with HALS report that body shape changes have been noticed by friends, family or work colleagues. HALS has been shown to adversely affect quality of life and may cause stigma, low self-esteem, anxiety and depression. CLA is a fatty acid found naturally in milk and dairy products. HALS has been suggested to occur as a result of antiretroviral drugs altering the ability of fat cells to store fat. When fat cells in the face, arms and legs no longer store fat correctly, this fat leaks from fat cells and is taken up by fat cells in the abdomen. Recent work by our group has shown that CLA is able to increase fat storage and improve fat cell function. The aim in this study is to investigate the effects of CLA on abdominal fat. Who can participate? Men with HIV who are receiving HAART and have a waist circumference greater than 94 cm (37 inches) or body-mass index greater than 25 kg/m2. What does the study involve? Participants will be randomly assigned to one of two groups: intervention (3 g CLA/day) or placebo (3 g high oleic sunflower oil) for 12 weeks. What are the possible benefits and risks of participating? A benefit is that the findings of this study will help identify whether CLA can reduce waist circumference and improve body fat abnormalities in men with HIV. Where is the study run from? St Thomas' Hospital (UK) When is the study starting and how long is it expected to run for? From January 2014 to April 2014 Who is funding the study? King's College London (UK) Who is the main contact? Dr Cathriona Loonam
Critère d'inclusion
- HIV-associated lipodystrophy