Effect of DHA on Lipid and Carbohydrate Metabolism Alterations and Body Fat Distribution in HIV Patients Under HAART.
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|ClinicalTrials.gov Identifier: NCT02005900|
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Highly active antiretroviral therapy (HAART) is able to cause lipid metabolism and glucose homeostasis alterations, which are associated to the redistribution of body fat. Alterations in lipid and carbohydrate metabolism contribute to the development of a highly atherogenic profile, which together with altered fibrinolysis markers and increased presence of proinflammatory cytokines in blood (especially tumor necrosis factor alpha) that comes associated to the success of HAART can cause the development of accelerated atherosclerosis. Docosahexaenoic acid (DHA) is a polyunsaturated fatty acid that has demonstrated its ability to reduce triglyceride levels; modify cholesterol fractions and increase the size of LDL particles thereby configuring less atherogenic plasma profile. Additionally, administration of DHA has shown antiinflammatory and hypotensive activity, which contributes to reduce the risk of cardiovascular complications in these patients. At a molecular level, DHA acts as a stimulator of the nuclear receptor PPAR-gamma, which has been described to induce an increase in adipocyte differentiation. Furthermore, the anti-inflammatory effects induced by DHA, can decrease the elevated levels of TNF-alpha, which has been implicated in the pathogenesis of body fat redistribution in HIV infected patients undergoing HAART. Therefore, the hypothesis of this project is that DHA will be able to produce lipid-lowering, anti-inflammatory, hypotensive and profibrinolytic effects, which all together should improve atherogenic profile of patients with HIV-1 infection receiving HAART. In addition, their proprieties as PPAR agonist can improve the redistribution of body fat present in many of these patients. The study of the activity of DHA on dendritic cells and monocytes should indicate the absence of immunosuppressive effect of DHA in the context of HIV-1 infection.
In summary, DHA is a natural product, from the omega 3 polyunsaturated fatty acids, the therapeutic properties of which have been described in recent years and has shown cardio-vascular and metabolic beneficial effects, without recognized side effects. The highly purified DHA administration at high doses could be able to reverse, at least partially, lipid abnormalities associated with HAART and to exert a beneficial effect on fat redistribution in HIV-infected patients treated with HAART. To ensure non deleterious immunological treat in these sensitive poly-medicated patients, substantial changes in the functionality of dendritic cells and monocytic will be studied.
|Condition or disease||Intervention/treatment||Phase|
|HIV-associated Hypertriglyceridemia HIV-associated Hypercholesterolemia HIV-associated Inflammatory State||Drug: Docosahexaenoic acid (DHA) administration to modulate Triglycerides in HIV patients under HAART||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-blind, Placebo-controlled, Randomized 48 Weeks of Duration Study. The Effect of the Administration of Docosahexaenoic Acid on Lipid and Carbohydrate Metabolism Alterations and Body Fat Distribution in Patients With HIV Infection Under High Activity Antiretroviral Treatment|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||October 2013|
Docosahexaenoic acid (DHA) administration to modulate Triglycerides in HIV patients under HAART
Drug: Docosahexaenoic acid (DHA) administration to modulate Triglycerides in HIV patients under HAART
Multicenter, prospective, double-blind, randomized study of 48 weeks duration, in which the effect of 4 g daily of DHA vs 4 g daily of placebo (oleic acid) are studied on modulation of the Triglycerides and other lipids in patients with HIV infection under HAART treatment.
|Placebo Comparator: PLACEBO|
- Triglyceride level [ Time Frame: 48 weeks ]Fasting Serum triglyceride level
- Fasting Serum total cholesterol level [ Time Frame: 48 weeks ]Fasting Serum total cholesterol level
- Lipid profile [ Time Frame: 48 weeks ]Fasting serum levels of LDL, HDL, and non-HDL cholesterol
- Inflammatory Cytokines [ Time Frame: 48 weeks ]TNF alpha, MCP-1, IL-1, and IL-6
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005900
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Principal Investigator:||Pere Domingo, PhD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|