Clinical trial NCT03416127: Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Official title: Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus type 2
Glycemic control
Propolis
Metformin
Pharmacological treatment-naïve patients
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting Serum Glucose
timeFrame: Week 12
measure: 2 Hours After Oral Glucose Tolerance Test in Week 12
timeFrame: Week 12
measure: Glycosylated Hemoglobin (A1C)
timeFrame: Week 12
Secondary outcomes:
measure: Total Insulin Secretion
timeFrame: Week 12
measure: Insulin Sensitivity
timeFrame: Week 12
measure: First Phase of Insulin Secretion
timeFrame: Week 12
measure: AUC Glucose
timeFrame: Week 12
measure: AUC Insulin
timeFrame: Week 12
measure: Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week
timeFrame: Week 12
measure: Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week
timeFrame: Week 12
measure: Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week
timeFrame: Week 12
measure: Waist Circumference
timeFrame: Week 12
measure: Body Weight
timeFrame: Week 12
measure: Body Mass Index
timeFrame: Week 12
measure: Percentage of Fat Mass
timeFrame: Week 12
measure: Total Cholesterol
timeFrame: Week 12
measure: Triglycerides
timeFrame: Week 12
measure: High Density Lipoprotein Cholesterol (c-HDL)
timeFrame: Week 12
measure: Low Density Lipoproteins Cholesterol (c-LDL)
timeFrame: Week 12
measure: Very Low Density Lipoprotein (c-VLDL)
timeFrame: Week 12
measure: Creatinine
timeFrame: Week 12
measure: Uric Acid
timeFrame: Week 12
measure: Systolic Blood Pressure
timeFrame: Week 12
measure: Diastolic Blood Pressure
timeFrame: Week 12
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: Intstituto de Terapeútica Experimental y Clínica.
name: MANUEL GONZALEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: