Insulin Resistance Clinical Trial
Official title:
The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
Spirulina, a widely used food supplement, improves the lipid profile and glycemic control in people living with diabetes, suggesting that it could have some effects on insulin sensitivity. Since HIV-infected patients develop metabolic abnormalities due to the virus and/or to antiretroviral (ARV) drugs, the investigators therefore proposed to evaluate the effect that spirulina can have on HIV/HAART-associated insulin resistance
Even though antiretroviral therapy (ART) has dramatically improved the health of people
living with HIV/AIDS, the prospect of maintaining patients long term on ART can be severely
restricted by the development of serious long term effects in their metabolism. These
abnormalities include dyslipidemia, lipodystrophy and disorders of glucose metabolism with
insulin resistance believed to be the underlying pathophysiological mechanism.
Spirulina, has recently drawn attention on its cholesterol and blood pressure lowering
effects, including improvement of glycaemic control in diabetics subjects, suggesting it can
have some effects on insulin sensitivity.
The aim of this three month, experimental, prospective, randomised trial was to evaluate the
effect of Spirulina on HIV/HAART-associated insulin resistance on 33 subjects. Primary
outcome was change in insulin sensitivity during the trial, over two time periods; t=0 and
t=12 weeks. The second objective was to compare between the two groups, the percentage of
subjects who improved insulin sensitivity by the end of the study.
Recruitment started in October 2008 and the trial ended in February 2009.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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