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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Metformin
Agave inulin
Placebo of agave inulin
Metformin placebo
Sponsored by
Centro Universitario de Ciencias de la Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Agave inulin, Adiponectin, Metabolic syndrome, Metformin, Insulin resistance

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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%)

Sites / Locations

  • Universidad de Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Agave inulin + Metformin

Metformin + Placebo of agave inulin

Agave Inulin+Placebo of Metformin

Placebo of Inulin + Placebo of Metformin

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline in Fasting plasma glucose at 12 weeks
Before and after intervention by glucose oxidase
Change from Baseline in Total cholesterol at 12 weeks
Before and after intervention by spectrophotometry
Change from Baseline in Triglycerides at 12 weeks
Before and after intervention by spectrophotometry
Change from baseline in High-density lipoprotein cholesterol at 12 weeks
Before and after intervention by spectrophotometry
Changes of Insulin levels from baseline to 12 weeks
Before and after intervention by ELISA
Change of HOMA-IR from base line to 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
Measured with a non elastic tape at baseline and after intervention
Change of body mass index
before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer
Change from baseline in Peripheral systolic blood pressure
Before and after intervention using a digital sphygmomanometer
Change from baseline in Peripheral diastolic blood pressure
Before and after intervention using a digital sphygmomanometer

Full Information

First Posted
May 12, 2016
Last Updated
May 17, 2016
Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02773927
Brief Title
Combination of Metformin/Inulin vs Inulin on Adiponectin in Metabolic Syndrome
Official Title
Effect of the Combination Metformin/Inulin vs Inulin on Adiponectin in Patients With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario de Ciencias de la Salud, Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Agave inulin, Adiponectin, Metabolic syndrome, Metformin, Insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Agave inulin + Metformin
Arm Type
Experimental
Arm Description
5 g of Agave inulin powder every 12 hrs + 500 mg tablet of metformin every 24 hrs
Arm Title
Metformin + Placebo of agave inulin
Arm Type
Active Comparator
Arm Description
500 mg tablet of metformin every 24 hrs + 5 g every 12 hrs of calcinated magnesia powder
Arm Title
Agave Inulin+Placebo of Metformin
Arm Type
Active Comparator
Arm Description
5 g of agave inulin powder every 12 hrs + 500 mg tablet of calcinated magnesia as metformin placebo every 24 hrs
Arm Title
Placebo of Inulin + Placebo of Metformin
Arm Type
Placebo Comparator
Arm Description
5 g of calcinated magnesia powder every 12 hrs + 500 mg tablet of calcinated magnesia every 24 hrs
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
GLUCOPHAGE
Intervention Description
Metformin in tablet presentation of 500 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Agave inulin
Intervention Description
Inulin in powder obtained from agave plant, it was given to each patient a full 10 mg container.
Intervention Type
Other
Intervention Name(s)
Placebo of agave inulin
Intervention Description
Calcinated magnesia powder
Intervention Type
Other
Intervention Name(s)
Metformin placebo
Intervention Description
Calcinated magnesia tablet
Primary Outcome Measure Information:
Title
Change from Baseline on adiponectin levels (ng/mL) at 12 weeks
Description
Before and after intervention determination of adiponectin using ELISA following the suppliers recommendations
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Fasting plasma glucose at 12 weeks
Description
Before and after intervention by glucose oxidase
Time Frame
12 weeks
Title
Change from Baseline in Total cholesterol at 12 weeks
Description
Before and after intervention by spectrophotometry
Time Frame
12 weeks
Title
Change from Baseline in Triglycerides at 12 weeks
Description
Before and after intervention by spectrophotometry
Time Frame
12 weeks
Title
Change from baseline in High-density lipoprotein cholesterol at 12 weeks
Description
Before and after intervention by spectrophotometry
Time Frame
12 weeks
Title
Changes of Insulin levels from baseline to 12 weeks
Description
Before and after intervention by ELISA
Time Frame
12 weeks
Title
Change of HOMA-IR from base line to 12 weeks
Description
Before and after intervention by using the formula for the homeostasis model assessment index (FI x (fasting glucose (mmol/l)/22.5)
Time Frame
12 weeks
Title
Change of waist circumference
Description
Measured with a non elastic tape at baseline and after intervention
Time Frame
12 weeks
Title
Change of body mass index
Description
before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer
Time Frame
12 weeks
Title
Change from baseline in Peripheral systolic blood pressure
Description
Before and after intervention using a digital sphygmomanometer
Time Frame
12 weeks
Title
Change from baseline in Peripheral diastolic blood pressure
Description
Before and after intervention using a digital sphygmomanometer
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Grover, PhD
Organizational Affiliation
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Guadalajara
City
Guadalajara
State/Province
Jalisco, México
ZIP/Postal Code
44100
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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