NCT02773927

Effect of the Combination Metformin/Inulin vs Inulin on Adiponectin in Patients With Metabolic Syndrome

Completed Phase 3 Last updated 17 May 2016

What this trial tests

Phase 3 trial testing Metformin in Metabolic Syndrome in 40 participants. Completed in 1 June 2015.

Timeline

1 January 2013

Primary endpoint
1 January 2014

1 June 2015

Quick facts

Lead sponsor	Centro Universitario de Ciencias de la Salud, Mexico
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	1 January 2013
Primary completion	1 January 2014
Estimated completion	1 June 2015
Sites	1 location across Mexico

Drugs / interventions tested

• Metformin (metformin) — full drug profile →
• Agave inulin — full drug profile →
• Placebo of agave inulin
• Metformin placebo

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Centro Universitario de Ciencias de la Salud, Mexico — full company profile →

Who can join

Adults 40 to 80, male only, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from Baseline on adiponectin levels (ng/mL) at 12 weeks
  Time frame: 12 weeks
  Before and after intervention determination of adiponectin using ELISA following the suppliers recommendations

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical epigenetics settings for cancer and cardiovascular diseases: real-life applications of network medicine at the bedside.
   Sarno F, Benincasa G, List M, Barabasi AL, et al · · 2021 · cited 49× · PMID 33785068 · DOI 10.1186/s13148-021-01047-z