Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773927
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Fernando Grover Paez, Centro Universitario de Ciencias de la Salud, Mexico

Tracking Information
First Submitted Date  ICMJE May 12, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date May 18, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
  • Change from Baseline in Fasting plasma glucose at 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by glucose oxidase
  • Change from Baseline in Total cholesterol at 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by spectrophotometry
  • Change from Baseline in Triglycerides at 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by spectrophotometry
  • Change from baseline in High-density lipoprotein cholesterol at 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by spectrophotometry
  • Changes of Insulin levels from baseline to 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by ELISA
  • Change of HOMA-IR from base line to 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by using the formula for the homeostasis model assessment index (FI x (fasting glucose (mmol/l)/22.5)
  • Change of waist circumference [ Time Frame: 12 weeks ]
    Measured with a non elastic tape at baseline and after intervention
  • Change of body mass index [ Time Frame: 12 weeks ]
    before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer
  • Change from baseline in Peripheral systolic blood pressure [ Time Frame: 12 weeks ]
    Before and after intervention using a digital sphygmomanometer
  • Change from baseline in Peripheral diastolic blood pressure [ Time Frame: 12 weeks ]
    Before and after intervention using a digital sphygmomanometer
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
  • Change from Baseline in Fasting plasma glucose at 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by glucose oxidase
  • Change from Baseline in Total cholesterol at 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by spectrophotometry
  • Change from Baseline in Triglycerides at 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by spectrophotometry
  • Change from baseline in High-density lipoprotein cholesterol at 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by spectrophotometry
  • Changes of Insulin levels from baseline to 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by ELISA
  • Change of HOMA-IR from base line to 12 weeks [ Time Frame: 12 weeks ]
    Before and after intervention by using the formula for the homeostasis model assessment β-cell function index: 20 x fasting insulin (µU/Ml)/fasting glucose (mmol/L) - 3.5.
  • Change of waist circumference [ Time Frame: 12 weeks ]
    Measured with a non elastic tape at baseline and after intervention
  • Change of body mass index [ Time Frame: 12 weeks ]
    before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer TBF-215 - Tanita)
  • Change from baseline in Peripheral systolic blood pressure [ Time Frame: 12 weeks ]
    Before and after intervention using a digital sphygmomanometer
  • Change from baseline in Peripheral diastolic blood pressure [ Time Frame: 12 weeks ]
    Before and after intervention using a digital sphygmomanometer
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Metformin/Inulin vs Inulin on Adiponectin in Metabolic Syndrome
Official Title  ICMJE Effect of the Combination Metformin/Inulin vs Inulin on Adiponectin in Patients With Metabolic Syndrome
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Drug: Metformin
    Metformin in tablet presentation of 500 mg
    Other Name: GLUCOPHAGE
  • Dietary Supplement: Agave inulin
    Inulin in powder obtained from agave plant, it was given to each patient a full 10 mg container.
  • Other: Placebo of agave inulin
    Calcinated magnesia powder
  • Other: Metformin placebo
    Calcinated magnesia tablet
Study Arms  ICMJE
  • Experimental: Agave inulin + Metformin
    5 g of Agave inulin powder every 12 hrs + 500 mg tablet of metformin every 24 hrs
    Interventions:
    • Drug: Metformin
    • Dietary Supplement: Agave inulin
  • Active Comparator: Metformin + Placebo of agave inulin
    500 mg tablet of metformin every 24 hrs + 5 g every 12 hrs of calcinated magnesia powder
    Interventions:
    • Drug: Metformin
    • Other: Placebo of agave inulin
  • Active Comparator: Agave Inulin+Placebo of Metformin
    5 g of agave inulin powder every 12 hrs + 500 mg tablet of calcinated magnesia as metformin placebo every 24 hrs
    Interventions:
    • Dietary Supplement: Agave inulin
    • Other: Metformin placebo
  • Placebo Comparator: Placebo of Inulin + Placebo of Metformin
    5 g of calcinated magnesia powder every 12 hrs + 500 mg tablet of calcinated magnesia every 24 hrs
    Interventions:
    • Other: Placebo of agave inulin
    • Other: Metformin placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2016)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773927
Other Study ID Numbers  ICMJE CUCS-INTEC-MV-HBP-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fernando Grover Paez, Centro Universitario de Ciencias de la Salud, Mexico
Study Sponsor  ICMJE Centro Universitario de Ciencias de la Salud, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fernando Grover, PhD Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
PRS Account Centro Universitario de Ciencias de la Salud, Mexico
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP