Combination of Metformin/Inulin vs Inulin on Adiponectin in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The main objective was to compare the effect of the administration of Metformin/agave inulin
      vs. Agave inulin on adiponectin in patients with MetS. The investigators conducted a
      double-blinded randomized trial, on 4 groups, each group with 10 male patients of 40-80 years
      of age with METS diagnosed by International Diabetes Federation (IDF) criteria. Randomization
      determined the group assignation during the 12-week trial, each group consisted of:

      Group (A) Metformin plus agave inulin: 10 individuals received metformin in a dosis of 500 mg
      per day (1 tablet of 500 mg) plus inulin in a dosis of 10 mg per day (5 mg every 12 hours)
      during 12 weeks.

      Group (B) Metformin plus Placebo of agave inulin: 10 individuals received Metformin in a
      dosis of 500mg per day (with the first bite of the second meal) plus homologue placebo of
      inulin (calcinated magnesia) in a dosis of 10 mg every 24 hrs (5 mg of calcinated magnesia
      powder every 12 hours) during 12 weeks.

      Group (C) Agave inulin plus Placebo of Metformin: 10 individuals received inulin in a dosis
      of 10 mg every 24 hrs (5 mg every 12 hours) plus homologate placebo of metformin (calcinated
      magnesia) in a dosis of 500 mg per day (with the first bite of the second meal) during 12
      weeks.

      Group (D) Placebo of Agave inulin plus Placebo of Metformin: homologate placebo of Inulin
      (calcinated magnesia powder) in a dosis of 10 mg every 24 hrs (5 mg every 12 hours) plus
      homologate placebo of metformin (calcinated magnesia capsules) in a dosis of 500 mg per day
      (with the first bite of the second meal) during 12 weeks.

      The clinical findings and laboratory test included a metabolic profile and biosafety, which
      was determined at baseline and at 12 weeks.

      Waist, body weight, body fat, body mass index (BMI) and blood pressure were determined at
      baseline, follow up and final visit, likewise, a blood sample was obtained, centrifuged and
      stored at -80° degrees Celsius to be analyzed after within 30 days. The investigators
      assessed glucose, total cholesterol, c-HDL, c-LDL, triglycerides by enzymatic techniques, and
      adiponectin and insulin by ELISA. Insulin resistance (IR) was estimated by the homeostasis
      model assessment (HOMA) with the formula for the HOMA (fasting insulin mcg/L x (fasting
      glucose (mmol/L)/22.5) Adverse events and adherence to treatment were documented every 4
      weeks.

      Statistical analysis: Values were expressed as mean and standard deviation. Mann-Whitney U
      Test, Wilcoxon exact test and Kruskal-Wallis. A statistical significance was set at p<0.05.
    

Intervention name(s): Metformin; Agave inulin; Placebo of agave inulin; Metformin placebo
Intervention type(s): Drug; Dietary Supplement; Other; Other
Intervention description(s): Metformin in tablet presentation of 500 mg; Inulin in powder obtained from agave plant, it was given to each patient a full 10 mg container.; Calcinated magnesia powder; Calcinated magnesia tablet
Other intervention name(s): GLUCOPHAGE
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Agave inulin; Adiponectin; Metabolic syndrome; Metformin; Insulin resistance