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Trial record 57 of 92 for:    high | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

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ClinicalTrials.gov Identifier: NCT03633630
Recruitment Status : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Esperanza Martínez-Abundis, University of Guadalajara

Brief Summary:
Amla has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Amla has an excellent potential for the prevention and treatment of metabolic syndrome.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Amla Drug: Placebo Phase 2 Phase 3

Detailed Description:
A randomized, double-blind, placebo-controlled clinical trial will be conducted in 28 patients, 30-59 years old, with diagnosis of Metabolic Syndrome according with modified International Diabetes Federation criteria. Patients will be randomly assigned to receive Amla (500mg) or homologated placebo orally twice daily, for 90 days. Before and after the intervention, the components of Metabolic Syndrome will be evaluated, waist circumference, blood pressure, levels of fasting glucose, triglycerides, cholesterol high density lipoprotein (C-HDL), total insulin secretion (Insulinogenic index), first phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Amla Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion.
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Amla (Emblica Officinalis)
1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days.
Drug: Amla
Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
Other Name: Emblica Officinalis

Placebo Comparator: Placebo
1000 mg dose per day. Two capsules of 500 mg, one in the morning before breakfast and the other before dinner during 90 days
Drug: Placebo
Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
Other Name: Calcined Magnesia




Primary Outcome Measures :
  1. Waist Circumference (WC) [ Time Frame: 90 days ]
    The WC will be evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest. The value will be expressed in centimeters.

  2. Triglycerides (TGs) [ Time Frame: 90 days ]
    The blood sample for determining of TGs, will be taken after an overnight fast and with a spectrophotometry method. The value will be expressed on mmol/L.

  3. High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: 90 days ]
    The blood sample for determining of HDL-C, will be taken after an overnight fast with a colorimetric method. The value will be expressed on mmol/L.

  4. Fasting Plasma Glucose (FPG) [ Time Frame: 90 days ]
    The blood sample for determining of FPG, will be taken after an overnight fast and with a spectrophotometry method. The value will be expressed on mmol/L.

  5. Systolic Blood Pressure (SBP) [ Time Frame: 90 days ]
    The SBP will be 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 will be considered as the value of SBP. The value will be expressed on mmHg.

  6. Diastolic Blood Pressure (DBP) [ Time Frame: 90 days ]
    The DBP will be 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 will be considered as the value of DBP. The value will be expressed on mmHg.



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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosed Metabolic Syndrome according to the IDF criteria:
  • - - Waist circumference: ≥80 cm (women) ≥90 cm (men), plus two or more of the following:
  • - - Fasting glucose ≥ 100 mg/dL to <126 mg/dL.
  • - - Triglycerides ≥150 mg/dL to <499 mg/dL
  • - - HDL-C: Men ≤40 mg/dL, women ≤50 mg/dL
  • - - Systolic blood pressure ≥130 to <140 mmHg
  • - - Diastolic blood pressure ≥85 to <89 mmHg
  • Body Mass Index between 25 and 34.9 kg/m²
  • No pharmacological treatment for Metabolic Syndrome

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Known allergy to Amla or placebo
  • History of hepatic, kidney or thyroid disease
  • Drugs or supplements consumption with proven properties that modify the behavior of the Metabolic Syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633630


Contacts
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Contact: Esperanza Martínez-Abundis, PhD 523310585200 ext 34211 esperanzamartnezabundi@yahoo.com
Contact: Mercedes Hernández-Jaime, PhD Student 523310585200 ext 34211 mercedes.hdezj@gmail.com

Locations
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Mexico
Institute of Experimental and Clinical Therapeutics Not yet recruiting
Guadalajara, Jalisco, Mexico, 44340
Contact: Mercedes Hernández-Jaime, PhD Student    523310585200 ext 34211    mercedes.hdezj@gmail.com   
Sponsors and Collaborators
University of Guadalajara
Investigators
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Principal Investigator: Esperanza Martínez-Abundis, PhD Institute of Experimental and Clinical Therapeutics

Publications:

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Responsible Party: Esperanza Martínez-Abundis, Researcher Professor, University of Guadalajara
ClinicalTrials.gov Identifier: NCT03633630     History of Changes
Other Study ID Numbers: Amla MS
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Esperanza Martínez-Abundis, University of Guadalajara:
Amla
Emblica officinalis
Metabolic Syndrome
Insulin Secretion
Insulin Sensitivity

Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Hypersensitivity
Insulin Resistance
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs