Combination of Metformin/Inulin vs Inulin on Adiponectin in Metabolic Syndrome

NCT02773927 | Completed Phase 3

• 1 other identifier: CUCS-INTEC-MV-HBP-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome

Keywords

Agave inulin; Adiponectin; Metabolic syndrome; Metformin; Insulin resistance

Outcome Measures

Primary Outcomes (1)

• Change from Baseline on adiponectin levels (ng/mL) at 12 weeks

  Before and after intervention determination of adiponectin using ELISA following the suppliers recommendations

  12 weeks

Secondary Outcomes (10)

• Change from Baseline in Fasting plasma glucose at 12 weeks

  12 weeks

• Change from Baseline in Total cholesterol at 12 weeks

  12 weeks

• Change from Baseline in Triglycerides at 12 weeks

  12 weeks

• Change from baseline in High-density lipoprotein cholesterol at 12 weeks

  12 weeks

• Changes of Insulin levels from baseline to 12 weeks

  12 weeks

Study Arms (4)

Agave inulin + Metformin

EXPERIMENTAL

5 g of Agave inulin powder every 12 hrs + 500 mg tablet of metformin every 24 hrs

Drug: Metformin; Dietary Supplement: Agave inulin

Metformin + Placebo of agave inulin

ACTIVE COMPARATOR

500 mg tablet of metformin every 24 hrs + 5 g every 12 hrs of calcinated magnesia powder

Drug: Metformin; Other: Placebo of agave inulin

Agave Inulin+Placebo of Metformin

ACTIVE COMPARATOR

5 g of agave inulin powder every 12 hrs + 500 mg tablet of calcinated magnesia as metformin placebo every 24 hrs

Dietary Supplement: Agave inulin; Other: Metformin placebo

Placebo of Inulin + Placebo of Metformin

PLACEBO COMPARATOR

5 g of calcinated magnesia powder every 12 hrs + 500 mg tablet of calcinated magnesia every 24 hrs

Other: Placebo of agave inulin; Other: Metformin placebo

Interventions

Metformin DRUG

Metformin in tablet presentation of 500 mg

Also known as: GLUCOPHAGE

Agave inulin + Metformin; Metformin + Placebo of agave inulin

Agave inulin DIETARY_SUPPLEMENT

Inulin in powder obtained from agave plant, it was given to each patient a full 10 mg container.

Agave Inulin+Placebo of Metformin; Agave inulin + Metformin

Placebo of agave inulin OTHER

Calcinated magnesia powder

Metformin + Placebo of agave inulin; Placebo of Inulin + Placebo of Metformin

Metformin placebo OTHER

Calcinated magnesia tablet

Agave Inulin+Placebo of Metformin; Placebo of Inulin + Placebo of Metformin

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of metabolic syndrome by IDF criteria
• a person to be defined as having the metabolic syndrome they must have: Central obesity (defined as waist circumference\* with ethnicity specific values) ≥80 cm in females and ≥90 cm in males; and plus any two of the following four factors:
• Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality Reduced HDL cholesterol
• \< 40 mg/dL (1.03 mmol/L) in males \< 50 mg/dL (1.29 mmol/L) in females or specific treatment for this lipid abnormality
• Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension
• Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
• Age ranging from 40 to 80 years old
• Male patients
• Informed written consent

You may not qualify if:

• Kidney disease
• Hepatic disease
• Thyroid disease
• Diabetes mellitus
• Ischemic heart disease
• Drug consumption
• Alcohol consumption of more than 2 ounces daily
• Consumption of drugs that intervene with lipid or glucose metabolism 2 months before
• Blood pressure \>160/100 mmHg.
• Lack of adherence to treatment (adherence \<80%)

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: lead

Study Sites (1)

Universidad de Guadalajara

Guadalajara, Jalisco, México, 44100, Mexico

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Fernando Grover, PhD

  Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fernando Grover-Paez, PhD

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 16, 2016
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2015
• Last Updated: May 18, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)