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Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03416127
Recruitment Status : Not yet recruiting
First Posted : January 30, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Manuel González Ortiz, University of Guadalajara

Brief Summary:

Glycemic control is naturally the principal topic of diabetes and complications that can be developed as a consequence of loss of sensitivity to perceive insulin signals by the cell. The glycemic control goals established by the ADA are: glycosylated hemoglobin (A1C) <7.0%, fasting plasma glucose 80-130 mg/dL and casual plasma glycemia <180 mg/dL. The first-line treatment in patients of recent diagnosis is metformin, however, studies have shown that propolis, a resinous balsamic material collected by the Apis mellifera bee, from sprouts, exudates of trees and other parts of the plants, represents a very important and promising natural alternative in medicine, which can be considered as an antidiabetic agent.

The aim of this study is to evaluate the effect of propolis or metformin administration on glycemic control in patients with type 2 Diabetes Mellitus without pharmacological treatment.

The investigators hypothesis is that propolis or metformin administration, modify the glycemic control in patients with type 2 Diabetes Mellitus without pharmacological treatment.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Propolis Drug: Metformin Drug: Placebo Phase 2

Detailed Description:

A double-blind, randomized clinical trial of three pharmacological groups in 36 patients with a diagnosis of diabetes mellitus type 2 in accordance with the American Diabetes Association (ADA) without treatment.

They will be assigned randomly three groups of 12 patients, each one will receive propolis 300 mg, metformin 850 mg and placebo, two times per day before having break-fast and before having dinner during 12 weeks.

The Area Under the Curve of glucose and insulin will be calculated, total insulin secretion (Insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propolis
Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.
Drug: Propolis
300 mg, two times per day before break-fast and dinner during 12 weeks.

Experimental: Metformin
Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
Drug: Metformin
850 mg, two times per day before break-fast and dinner during 12 weeks.

Placebo Comparator: Placebo
Placebo capsules, two times per day before break-fast and dinner during 12 weeks.
Drug: Placebo
Two times per day before break-fast and dinner during 12 weeks.
Other Name: Calcined magnesium




Primary Outcome Measures :
  1. Changes in fasting glucose levels after 12 weeks of intervention with propolis, metformin and placebo [ Time Frame: Baseline to Week 12 ]
    The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12

  2. Changes in postprandial glucose levels after 12 weeks of intervention with propolis, metformin and placebo [ Time Frame: Baseline to Week 12 ]
    Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12

  3. Changes in glycosylated hemoglobin (A1C) after 12 weeks of intervention with propolis, metformin and placebo [ Time Frame: Baseline to Week 12 ]
    Glycosylated hemoglobin will be evaluated at baseline and week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12


Secondary Outcome Measures :
  1. Total insulin secretion [ Time Frame: Baseline to Week 12 ]
    Total insulin secretion will be calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12

  2. Insulin sensitivity [ Time Frame: Baseline to Week 12 ]
    Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12

  3. First phase of insulin secretion [ Time Frame: Baseline to Week 12 ]
    The first phase of insulin secretion will be calculated at baseline and week 12 with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12

  4. Waist Circumference [ Time Frame: Baseline, week 4, week 8 and Week 12 ]
    Waist circumference will be evaluated at baseline and at week 12 with a flexible tape

  5. Body Weight [ Time Frame: Baseline, week 4, week 8 and week 12 ]
    The body weight will be measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12

  6. Body Mass Index [ Time Frame: Baseline, week 4, week 8 and week 12 ]
    Body Mas Index will be calculated at baseline, week 4, week 8 and week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12

  7. Total Cholesterol [ Time Frame: Baseline to Week 12 ]
    Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12

  8. Triglycerides levels [ Time Frame: Baseline to Week 12 ]
    Triglycerides levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12

  9. High Density Lipoprotein (c-HDL) levels [ Time Frame: Baseline to Week 12 ]
    c-HDL levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12

  10. Low Density Lipoproteins (c-LDL) levels [ Time Frame: Baseline to Week 12 ]
    c-LDL levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12

  11. Creatinine levels [ Time Frame: Baseline to Week 12 ]
    Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques

  12. Uric acid levels [ Time Frame: Baseline to Week 12 ]
    Uric acid levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques

  13. Alanine aminotransferase (ALT) levels [ Time Frame: Baseline to Week 12 ]
    ALT levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques

  14. Aspartate aminotransferase (AST) levels [ Time Frame: Baseline to Week 12 ]
    AST levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques

  15. Blood pressure [ Time Frame: Baseline to Week 12 ]
    Blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients both sexes
  • Age between 30 and 60 years
  • Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels >126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose >200 mg/dl; or glycosylated hemoglobin between >6.5%)
  • Informed consent signed

Exclusion Criteria:

  • Women with confirmed or suspected pregnancy
  • Women under lactation and/or puerperium
  • Previous treatment for glucose
  • Fasting glucose ≥250 mg/dL
  • Body Mass Index ≥34.9 kg/m2
  • Known uncontrolled renal, hepatic, heart or thyroid diseased
  • Hypersensibility to ingredients of intervention
  • Known allergies to bee stings or their derived products
  • Triglycerides ≥500 mg/dL
  • Total cholesterol ≥240 mg/dL
  • Low density lipoprotein (c-LDL) ≥190 mg/dL
  • Blood Pressure ≥140/90 mmHg

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): NCT03416127


Contacts
Contact: MANUEL GONZALEZ-ORTIZ, PhD +523310585200 ext 34212 uiec@prodigy.net.mx
Contact: KARINA PEREZ RUBIO, PhD +523310585200 ext 34212 karina2410@hotmail.com

Locations
Mexico
Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara Not yet recruiting
Guadalajara, Jalisco, Mexico, 44340
Contact: MANUEL GONZALEZ, PhD    +523310585200 ext 34212    uiec@prodigy.net.mx   
Contact: KARINA PEREZ RUBIO, PhD    +523310585200 ext 34212    karina2410@hotmail.com   
Sponsors and Collaborators
University of Guadalajara
Investigators
Principal Investigator: MANUEL GONZALEZ, PhD Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Responsible Party: Manuel González Ortiz, Researcher Professor, University of Guadalajara
ClinicalTrials.gov Identifier: NCT03416127     History of Changes
Other Study ID Numbers: PROPOLIS-METFORMIN-DM2
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

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

Keywords provided by Manuel González Ortiz, University of Guadalajara:
Diabetes Mellitus type 2
Glycemic control
Propolis
Metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Propolis
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Infective Agents