Metabolic Syndrome Clinical Trial
Official title:
Effect of the Administration of Conjugated Linoleic Acid / Leucine Plus Metformin on Visceral Fat in Patients With Metabolic Syndrome
In Mexico, obesity is a major public health problem. In recent years he has presented a
considerable increase in the population. As a result, it has triggered a proportional
increase in the incidence of cardiovascular disease and the development of Metabolic Syndrome
(METS). Abdominal obesity is one of the main components of METS which is generally associated
with insulin resistance / hyperinsulinemia. This is influenced both by the subcutaneous
adipose tissue as visceral adipose tissue. There is evidence that the visceral fat has an
important bearing on many factors of METS, like: glucose intolerance, hypertension,
dyslipidemia, and insulin resistance.
For management it requires a multidisciplinary approach, including changes in lifestyle,
psychological and nutritional intervention as well as pharmacological and non-pharmacological
support.
Among non-pharmacological therapies, there is recently the use of Conjugated Linoleic Acid
(ACL) and leucine where in its assigned properties include weight reduction, anti-atherogenic
, hypocholesterolemic and immunostimulant effect and anticarcinogenic properties. Regarding
weight reduction dominates the mechanism of action anti-lipolytic effect. But, studies are
needed to link this consumption with the increase or decrease on visceral fat in individuals
with METS.
The main objective is to compare the effect of the administration of ACL/Leucine vs.
Metformin on visceral fat area in patients with METS. We will conduct a double-blind trial,
randomized, on 4 groups, each group with 26 male and female patients of 35-65 years of age
with METS diagnosed by IDF criteria. Randomization will determine who will receive the
intervention during 8 week trial, each group will be like:
Group (A) intervention with ACL/Leucine plus Metformin: 26 individuals will receive
ACL/Leucine in a dosis of 2,475mg per 24 hrs (1,650mg or 2 capsules with the first meal and
825 mg or 1 capsule with the second meal) plus Metformin in a dose of 500 mg per day (with
the first bite of the second meal) during 8 weeks.
Group (B) Metformin plus Placebo of ACL/Leucine: 26 individuals will receive Metformin in a
dose of 500 mg per day (with the first bite of the second meal) plus homologue placebo of
ACL/Leucine (linseed oil capsules) in a dosis of 3600 mg each 24 hrs (2 capsules of 2400 mg
with the first meal and 1200 mg or 1 capsule with the second meal) during 8 weeks.
Group (C) ACL/Leucine plus Metformin's Placebo: 26 individuals will receive ACL/Leucine in a
dose of 2,475mg per 24 hrs (1,650mg or 2 capsules with the first meal and 825 mg or 1 capsule
with the second meal) plus homologate placebo of metformin (calcined magnesia) in a dose of
500 mg per day (with the first bite of the second meal) during 8 weeks.
Group (D) Placebo of ACL/Leucine plus Placebo of Metformin: homologate placebo of ACL/Leucine
(linseed oil capsules) in a dose of 3600 mg each 24 hrs (2 capsules of 2400 mg with the first
meal and 1200 mg or 1 capsule with the second meal) plus homologated placebo of metformin
(calcined magnesia capsules) in a dosis of 500 mg per day (with the first bite of the second
meal) during 8 weeks.
The clinical findings and laboratory test include a metabolic profile and biosafety, which
will be baseline and at 8 weeks.
Visceral fat area, epicardial fat, body weight, body fat, body mass index (BMI) and blood
pressure will be determined during the inicial and final visit, likewise, hemodynamics
parameters of arterial stiffness like aortic pulse wave velocity (PWVao), central pulse
pressure (PPao), aortic augmentation index (IAxao) and central systolic blood pressure (cSBP)
by an oscillometric monitoring system via BPLab ®. Adverse events and adherence to treatment
will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. It is
considered with significance at p<0.05.
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