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Completed

NCT Number: NCT03416127

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

The aim of this study was to evaluate the effect of propolis or metformin on glycemic control in patients with type 2 diabetes mellitus without pharmacological treatment.

All patients received for 12 weeks propolis, metformin or placebo. Fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, a metabolic profile, areas under the curve of glucose and insulin, insulinogenic index, Stumvoll index, and Matsuda index were measured.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

About this study

A randomized, double-blind, placebo-controlled clinical trial of three pharmacological groups was carried out, with the participation of 36 patients with type 2 Diabetes Mellitus without pharmacological treatment.

At the beginning and end of the study, fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, and a metabolic profile were measured. Areas under the curve of glucose and insulin, total insulin secretion insulinogenic index), the first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index) were calculated.

All patients received for 12 weeks two capsules a day, one before the first bite of breakfast and another before the first bite of dinner. 12 of them took propolis (300 mg), another 12 received metformin (850 mg), and 12 more placebo in the same pharmacological presentation.

This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.

Results are presented as mean and standard deviation. Intra-group differences were evaluated using Kruskal-Wallis and Mann-Whitney U-tests, while inter-group differences were calculated with the Wilcoxon test; p≤0.05 was considered significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients both sexes
  • Age between 30 and 60 years
  • Mild to moderate physical activity
  • Stable body weight for at least 12 weeks prior to the study
  • BMI 25.0 - 34.9 kg/m2
  • Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels >126 mg/dl; or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose >200 mg/dl
  • 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
  • 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

Treatment and study plan

Propolis

Drug

Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.

metformin

Drug

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

Other names: Metformin hydrochloride

Placebo

Drug

Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.

Other names: Calcined magnesium

Primary outcomes

  1. Fasting Serum Glucose

    Time frame: Week 12

    The fasting glucose levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12

  2. 2 Hours After Oral Glucose Tolerance Test in Week 12

    Time frame: Week 12

    2-h serum glucose levels were evaluated at week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12

  3. Glycosylated Hemoglobin (A1C)

    Time frame: Week 12

    Glycosylated hemoglobin was evaluated at week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12

Secondary outcomes

  1. Total Insulin Secretion

    Time frame: Week 12

    Total insulin secretion was calculated at week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12.

    The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.

    Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion

  2. Insulin Sensitivity

    Time frame: Week 12

    Insulin sensitivity was calculated at week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12.

    Matsuda Index value is used to indicate insulin resistance on diabetes. 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)]. The entered values reflect the insulin sensitivity

  3. First Phase of Insulin Secretion

    Time frame: Week 12

    The first phase of insulin secretion was calculated at week 12 with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12.

    Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.

    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'), the entered values reflect the first phase of insulin secretion

  4. AUC Glucose

    Time frame: Week 12

    Area under the curve (AUC) of glucose was calculated with the polygonal formula.

    The area under the curve (AUC) of glucose, (0.5 * glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 * G 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia.

  5. AUC Insulin

    Time frame: Week 12

    Area under the curve (AUC) of insulin was calculated with the polygonal formula.

    The area under the curve (AUC) of insulin, (0.5 * Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 * I 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia.

  6. Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week

    Time frame: Week 12

    The glucose levels 30' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 30' at week 12

  7. Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week

    Time frame: Week 12

    The glucose levels 60' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 60' at week 12

  8. Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week

    Time frame: Week 12

    The glucose levels 90' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 90' at week 12.

  9. Waist Circumference

    Time frame: Week 12

    Waist circumference was evaluated at week 12 with a flexible tape

  10. Body Weight

    Time frame: Week 12

    The body weight was measured at week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12

  11. Body Mass Index

    Time frame: Week 12

    Body Mas Index was calculated at week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12

  12. Percentage of Fat Mass

    Time frame: Week 12

    Percentage of fat mass was evaluated through bioimpedance.

  13. Total Cholesterol

    Time frame: Week 12

    Total cholesterol levels were evaluated at week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12

  14. Triglycerides

    Time frame: Week 12

    Triglycerides levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12

  15. High Density Lipoprotein Cholesterol (c-HDL)

    Time frame: Week 12

    c-HDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12

  16. Low Density Lipoproteins Cholesterol (c-LDL)

    Time frame: Week 12

    c-LDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12

  17. Very Low Density Lipoprotein (c-VLDL)

    Time frame: Week 12

    Very low density lipoprotein (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.

  18. Creatinine

    Time frame: Week 12

    Creatinine levels were evaluated at week 12 with enzymatic/colorimetric techniques

  19. Uric Acid

    Time frame: Week 12

    Uric acid levels were evaluated at week 12 with enzymatic/colorimetric techniques

  20. Systolic Blood Pressure

    Time frame: Week 12

    The systolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12.

  21. Diastolic Blood Pressure

    Time frame: Week 12

    The diastolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2018
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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