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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2022
• Main ID: NCT03416127
• Date of registration: 23/01/2018
• Prospective Registration: Yes
• Primary sponsor: University of Guadalajara
• Public title: Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus
• Scientific title: Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment
• Date of first enrolment: January 30, 2018
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03416127
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Mexico

Contacts

• Name: MANUEL GONZALEZ, PhD
• Affiliation: Intstituto de Terapeútica Experimental y Clínica.

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Propolis

Drug: Metformin

Drug: Placebo

Primary Outcome(s)

Glycosylated Hemoglobin (A1C) [Time Frame: Week 12]

2 Hours After Oral Glucose Tolerance Test in Week 12 [Time Frame: Week 12]

Fasting Serum Glucose [Time Frame: Week 12]

Secondary Outcome(s)

First Phase of Insulin Secretion [Time Frame: Week 12]

AUC Insulin [Time Frame: Week 12]

Body Mass Index [Time Frame: Week 12]

Body Weight [Time Frame: Week 12]

Very Low Density Lipoprotein (c-VLDL) [Time Frame: Week 12]

Waist Circumference [Time Frame: Week 12]

High Density Lipoprotein Cholesterol (c-HDL) [Time Frame: Week 12]

Total Cholesterol [Time Frame: Week 12]

AUC Glucose [Time Frame: Week 12]

Creatinine [Time Frame: Week 12]

Insulin Sensitivity [Time Frame: Week 12]

Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week [Time Frame: Week 12]

Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week [Time Frame: Week 12]

Systolic Blood Pressure [Time Frame: Week 12]

Uric Acid [Time Frame: Week 12]

Total Insulin Secretion [Time Frame: Week 12]

Triglycerides [Time Frame: Week 12]

Diastolic Blood Pressure [Time Frame: Week 12]

Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week [Time Frame: Week 12]

Low Density Lipoproteins Cholesterol (c-LDL) [Time Frame: Week 12]

Percentage of Fat Mass [Time Frame: Week 12]

Secondary ID(s)

PROPOLIS-METFORMIN-DM2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03416127