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Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients (GUATECO)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Guazuma Ulmifolia plus Tecoma Stans
Calcinaned magnesia
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 Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signing of letter of consent under written information.
  • Men and women with serum glucose of ≥126 and <400 mg / dl and / or HbA1c ≥6.5% and <10%.
  • Age between 30 and 60 years.
  • BMI between 25 - 39.9 kg / m2.
  • With or without pharmacological treatment with oral hypoglycemic agents or insulin
  • Stable body weight during the last 3 months (± 5%).
  • Women in the follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of the laboratory tests
  • Women who do not expect to be pregnant within the next 3 months.

Exclusion Criteria:

  • Physical or mental incapacity that makes it impossible to carry out the intervention.
  • Uncontrolled thyroid disease
  • Women with suspicion or confirmation of pregnancy.
  • Women who are breastfeeding.
  • Hepatic disease or elevation to double the upper normal value of TGO and TGP.
  • Diagnosis of renal insufficiency or creatinine> 1.5 mg / dL or glomerular filtration rate <60 mL / min).
  • Known hypersensitivity to calcined magnesia or Guazuma ulmifolia and / or Tecoma stans.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Guazuma ulmifolia plus Tecoma stans

    Arm Description

    The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days.

    The patients were randomly assigned to received the herbarium mixture (GU/TS) , 1 capsule of 400mg, before each meal for a period of 90 days.

    Outcomes

    Primary Outcome Measures

    Modification in fasting glucose in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
    In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, glucose was measured in mg/dL, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
    Modification in HbA1c in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
    In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, HbA1c was measured in %, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.

    Secondary Outcome Measures

    Change in lipid profile in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
    In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, lipid profile was measured in mg/dL, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
    Modification in insulin in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
    In both groups (intervention and placebo ) of 20 patients each, all patients with type 2 diabetes mellitus, insulin was measured in uU/mL, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
    Hepatic safety of administration of guazuma, tecoma through the determination of hepatic profile
    The hepatic profile was determined through the serum levels of transaminases in U/L (Glutamic oxalacetic transaminase and Glutamic pyruvic transaminase) after of administration during 90 days of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg). The patient was on a 12-hour fast.
    Renal safety of administration of guazuma, tecoma through the determination of serum creatinine
    The serum creatinine was measured in mg/dL, before and after of administration during 90 days of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg). The patient was on a 12-hour fast.

    Full Information

    First Posted
    September 27, 2017
    Last Updated
    October 17, 2017
    Sponsor
    Centro Universitario de Ciencias de la Salud, Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03313856
    Brief Title
    Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients
    Acronym
    GUATECO
    Official Title
    Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2010 (Actual)
    Primary Completion Date
    December 31, 2010 (Actual)
    Study Completion Date
    May 31, 2011 (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

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the effect of oral administration of herbarium mixture Guazuma ulmifolia (GU) and Tecoma stans (TS) on metabolic profile in type 2 diabetic patients.
    Detailed Description
    A randomized, double blind, placebo controlled, clinical trial was carried out 40 type 2 diabetic patients independently of their basal hypoglycemic treatment. At beginning and at end of the study, BMI, waist circumference, a metabolic profile (fasting glucose, HbA1c, lipids and biosecurity profile), were measured. The patients were randomly assigned to receive the herbarium mixture (GU/TS) 1 g before each meal, or placebo for a period of 90 days. All patients received therapy medical nutrition.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two study groups were formed that were randomly assigned with the closed envelope technique to the corresponding group. Group Placebo vs. Guazuma ulmifolia plusTecoma stans
    Masking
    ParticipantInvestigator
    Masking Description
    Simple random. It was done with a table of numbers using random selection program Excel 2010.
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule before each meal for a period of 90 days.
    Arm Title
    Guazuma ulmifolia plus Tecoma stans
    Arm Type
    Experimental
    Arm Description
    The patients were randomly assigned to received the herbarium mixture (GU/TS) , 1 capsule of 400mg, before each meal for a period of 90 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Guazuma Ulmifolia plus Tecoma Stans
    Other Intervention Name(s)
    GUATECO
    Intervention Description
    Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule
    Intervention Type
    Drug
    Intervention Name(s)
    Calcinaned magnesia
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Calcined magnesia 400 mg per capsule
    Primary Outcome Measure Information:
    Title
    Modification in fasting glucose in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
    Description
    In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, glucose was measured in mg/dL, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
    Time Frame
    90 days
    Title
    Modification in HbA1c in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
    Description
    In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, HbA1c was measured in %, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Change in lipid profile in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
    Description
    In both groups (intervention and placebo ) of 20 patients each , all patients with type 2 diabetes mellitus, lipid profile was measured in mg/dL, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
    Time Frame
    90 days
    Title
    Modification in insulin in patients with type 2 diabetes after of administration of combination with Guazuma ulmifolia and Tecoma stans
    Description
    In both groups (intervention and placebo ) of 20 patients each, all patients with type 2 diabetes mellitus, insulin was measured in uU/mL, before and after the administration of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg), one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.
    Time Frame
    90 days
    Title
    Hepatic safety of administration of guazuma, tecoma through the determination of hepatic profile
    Description
    The hepatic profile was determined through the serum levels of transaminases in U/L (Glutamic oxalacetic transaminase and Glutamic pyruvic transaminase) after of administration during 90 days of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg). The patient was on a 12-hour fast.
    Time Frame
    90 days
    Title
    Renal safety of administration of guazuma, tecoma through the determination of serum creatinine
    Description
    The serum creatinine was measured in mg/dL, before and after of administration during 90 days of the combination guazuma ulmifolia (313.6 mg) and tecoma stans (86.4 mg). The patient was on a 12-hour fast.
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signing of letter of consent under written information. Men and women with serum glucose of ≥126 and <400 mg / dl and / or HbA1c ≥6.5% and <10%. Age between 30 and 60 years. BMI between 25 - 39.9 kg / m2. With or without pharmacological treatment with oral hypoglycemic agents or insulin Stable body weight during the last 3 months (± 5%). Women in the follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of the laboratory tests Women who do not expect to be pregnant within the next 3 months. Exclusion Criteria: Physical or mental incapacity that makes it impossible to carry out the intervention. Uncontrolled thyroid disease Women with suspicion or confirmation of pregnancy. Women who are breastfeeding. Hepatic disease or elevation to double the upper normal value of TGO and TGP. Diagnosis of renal insufficiency or creatinine> 1.5 mg / dL or glomerular filtration rate <60 mL / min). Known hypersensitivity to calcined magnesia or Guazuma ulmifolia and / or Tecoma stans.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients

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