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Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
Gymnema Sylvestre
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Gymnema Sylvestre, Insulin Secretion, Insulin Sensitivity, Central Obesity

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Letter of consent and release signed by each patient
  • Body mass index: 25-34.99 kg/m2
  • Body weight without variations above or under 5% during the three months prior to the study
  • Diagnostic of metabolic syndrome according to the modified International Diabetes Federation definition: Central obesity (defined as waist circumference ≥ 80 cm in women and ≥ 90 cm in men)

Plus any two of the following four factors:

  • Triglycerides: 150-499 mg/dL.
  • High density lipoprotein: Woman < 50 mg/dL, man < 40 mg/dL.
  • Blood pressure systolic:130-139 mmHg and/or Blood pressure diastolic: 85-89 mmHg
  • Fasting glucose: 100-125 mg/dL

Exclusion Criteria:

  • Type 1 or 2 diabetes mellitus
  • Previous pharmacological treatment for components of metabolic syndrome
  • Mental or physical illness interfering with the study
  • Thyroid or cardiovascular disease
  • Pregnant or suspected pregnant women
  • Woman breastfeeding
  • Index of body mass: ≥ 35 kg/m2
  • Treatments known to affect metabolism of glucose, fats and affecting arterial tension
  • Patients with hepatic or renal diseases background
  • Patients diagnosed with kidneys disease
  • Calcined magnesium intolerance
  • Gymnema Sylvestre intolerance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Gymnema Sylvestre

    Arm Description

    600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.

    600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.

    Outcomes

    Primary Outcome Measures

    Waist Circumference (WC)
    The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.
    Triglycerides (TGs)
    The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
    High-density Lipoprotein Cholesterol (HDL-C)
    The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.
    Fasting Plasma Glucose (FPG)
    The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
    Systolic Blood Pressure (SBP)
    The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.
    Diastolic Blood Pressure (DBP)
    The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.
    Total Insulin Secretion
    The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).
    First Phase of Insulin Secretion
    The first phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0').
    Insulin Sensitivity
    The insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)].

    Secondary Outcome Measures

    Body Weight (BW)
    The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.
    Body Mass Index (BMI)
    The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
    Total Cholesterol (TC)
    The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
    Low-density Lipoprotein Cholesterol (LDL-C)
    The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.
    Very-low Density Lipoprotein (VLDL)
    The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.
    2-hour Postload Plasma Glucose (2-h PG)
    The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
    Area Under the Curve of Glucose (AUCG)
    The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.
    Area Under the Curve of Insulin (AUCI)
    The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.

    Full Information

    First Posted
    February 17, 2015
    Last Updated
    June 8, 2019
    Sponsor
    University of Guadalajara
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02370121
    Brief Title
    Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin
    Official Title
    Effect of Gymnema Sylvestre Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Guadalajara

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome.
    Detailed Description
    A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the modify International Diabetes Federation criteria. The patients received 300 mg capsules of Gymnema sylvestre or placebo, two times daily before breakfast and dinner for 90 days. Before and after intervention the investigators evaluated: The components of metabolic syndrome (waist circumference, triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight, body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase. Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    Gymnema Sylvestre, Insulin Secretion, Insulin Sensitivity, Central Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
    Arm Title
    Gymnema Sylvestre
    Arm Type
    Experimental
    Arm Description
    600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Calcined Magnesia
    Intervention Description
    Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Gymnema Sylvestre
    Other Intervention Name(s)
    Gurmar
    Intervention Description
    Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
    Primary Outcome Measure Information:
    Title
    Waist Circumference (WC)
    Description
    The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.
    Time Frame
    Week 12
    Title
    Triglycerides (TGs)
    Description
    The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
    Time Frame
    week 12
    Title
    High-density Lipoprotein Cholesterol (HDL-C)
    Description
    The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.
    Time Frame
    Week 12
    Title
    Fasting Plasma Glucose (FPG)
    Description
    The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
    Time Frame
    week 12
    Title
    Systolic Blood Pressure (SBP)
    Description
    The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.
    Time Frame
    week 12
    Title
    Diastolic Blood Pressure (DBP)
    Description
    The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.
    Time Frame
    week 12
    Title
    Total Insulin Secretion
    Description
    The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).
    Time Frame
    Week 12
    Title
    First Phase of Insulin Secretion
    Description
    The first phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0').
    Time Frame
    week 12
    Title
    Insulin Sensitivity
    Description
    The insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)].
    Time Frame
    week 12
    Secondary Outcome Measure Information:
    Title
    Body Weight (BW)
    Description
    The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.
    Time Frame
    week 12
    Title
    Body Mass Index (BMI)
    Description
    The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
    Time Frame
    week 12
    Title
    Total Cholesterol (TC)
    Description
    The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
    Time Frame
    week 12
    Title
    Low-density Lipoprotein Cholesterol (LDL-C)
    Description
    The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.
    Time Frame
    Week 12
    Title
    Very-low Density Lipoprotein (VLDL)
    Description
    The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.
    Time Frame
    week 12
    Title
    2-hour Postload Plasma Glucose (2-h PG)
    Description
    The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
    Time Frame
    week 12
    Title
    Area Under the Curve of Glucose (AUCG)
    Description
    The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.
    Time Frame
    week 12
    Title
    Area Under the Curve of Insulin (AUCI)
    Description
    The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.
    Time Frame
    week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Letter of consent and release signed by each patient Body mass index: 25-34.99 kg/m2 Body weight without variations above or under 5% during the three months prior to the study Diagnostic of metabolic syndrome according to the modified International Diabetes Federation definition: Central obesity (defined as waist circumference ≥ 80 cm in women and ≥ 90 cm in men) Plus any two of the following four factors: Triglycerides: 150-499 mg/dL. High density lipoprotein: Woman < 50 mg/dL, man < 40 mg/dL. Blood pressure systolic:130-139 mmHg and/or Blood pressure diastolic: 85-89 mmHg Fasting glucose: 100-125 mg/dL Exclusion Criteria: Type 1 or 2 diabetes mellitus Previous pharmacological treatment for components of metabolic syndrome Mental or physical illness interfering with the study Thyroid or cardiovascular disease Pregnant or suspected pregnant women Woman breastfeeding Index of body mass: ≥ 35 kg/m2 Treatments known to affect metabolism of glucose, fats and affecting arterial tension Patients with hepatic or renal diseases background Patients diagnosed with kidneys disease Calcined magnesium intolerance Gymnema Sylvestre intolerance
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Esperanza Martínez, PhD
    Organizational Affiliation
    Institute of Experimental and Clinical Therapeutics
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

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