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

NCT03416127 | Completed Phase 2 Results

• 1 other identifier: PROPOLIS-METFORMIN-DM2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus type 2; Glycemic control; Propolis; Metformin; Pharmacological treatment-naïve patients

Outcome Measures

Primary Outcomes (3)

• Fasting Serum Glucose

  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

  Week 12

• 2 Hours After Oral Glucose Tolerance Test in 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

  Week 12

• Glycosylated Hemoglobin (A1C)

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

  Week 12

Secondary Outcomes (21)

• Total Insulin Secretion

  Week 12

• Insulin Sensitivity

  Week 12

• First Phase of Insulin Secretion

  Week 12

• AUC Glucose

  Week 12

• AUC Insulin

  Week 12

Study Arms (3)

Propolis

EXPERIMENTAL

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

Drug: Propolis

Metformin

EXPERIMENTAL

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

Drug: Metformin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Propolis DRUG

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

Propolis

Metformin DRUG

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

Also known as: Metformin hydrochloride

Metformin

Placebo DRUG

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

Also known as: Calcined magnesium

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Propolis; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: DR. MANUEL GONZALEZ ORTIZ
• Organization: INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA

uiec@prodigy.net.mx

+52 3310585200

Study Officials

• MANUEL GONZALEZ, PhD

  Intstituto de Terapeútica Experimental y Clínica.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Professor

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: January 30, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: November 7, 2022
• Results First Posted: October 9, 2020

Record last verified: 2022-11

Locations

ME (1)