Combination of Metformin/Inulin vs Inulin on Adiponectin in Metabolic Syndrome
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Presence of metabolic syndrome (MetS) and its relation with insulin resistance, obesity,
dyslipidemia, systemic inflammation and cardiovascular disease is of great concern. The study
of certain adipokines such as adiponectin has demonstrated an inverse association with
insulin resistance, especially in Latin population lower levels of adiponectin have been
observed compared to other ethnic groups. It appears to be an important molecule that is
involved in limiting the pathogenesis of obesity-linked disorders and may have potential
benefits as a marker to evaluate the effect of possible interventions on the MetS components
and its complications.
Metformin is treatment of choice in patients with MetS, due to its low cost and
pharmacological comparable effects with thiazolidinediones (pioglitazone), it decreases
hyperinsulinemia, insulin resistance, free fatty acids and triglycerides, it produces as
well, a moderate weight loss, improves lipid profile and delays the appearance of diabetes
mellitus in subjects with an abnormal fasting glucose.
A second choice to lower the risks would be the addition of a fiber like inulin, a prebiotic,
since it has demonstrated metabolic benefits on lipid and carbohydrates metabolism by several
mechanisms proposed such as induction of lipogenic enzymes by glucose, production of
short-chained fatty acids, glucose-dependent insulinotropic peptide (GIP) and glucagon-like
peptide-1 (GLP-1), and growth of Bifidobacterium. A good natural source of inulin is the
agave.
It is expected that the combination of metformin plus agave inulin will produce a beneficial
impact through pharmacological synergism and that will produce changes in the pathophysiology
of MetS.
Phase:
Phase 3
Details
Lead Sponsor:
Centro Universitario de Ciencias de la Salud, Mexico