Effect of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 5 June 2023
• Main ID: NCT03029390
• Date of registration: 20/01/2017
• Prospective Registration: No
• Primary sponsor: University of Guadalajara
• Public title: Effect of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes
• Scientific title: Effect of Administration of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Prediabetes
• Date of first enrolment: March 2016
• Target sample size: 28
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03029390
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: KARINA GRISELDA PEREZ, PhD
• Affiliation: University of Guadalajara

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients both sexes

- Age between 31 and 60 years

- Diagnosis of prediabetes according 2 ADA criteria (fasting blood glucose levels
between 100-125 mg/dl and postprandial blood glucose levels after an oral glucose
tolerance test with 75 of oral glucose between 140-199 mg/dl)

- Body Mass Index from 25 to 34.9kg/m2

- Informed consent signed

Exclusion Criteria:

- Women with confirmed or suspected pregnancy

- Women under lactation and/or puerperium

- Hypersensibility to ingredients of intervention

- Physical impossibility for taking pills

- Known uncontrolled renal, hepatic, heart or thyroid diseased

- Diabetes diagnosis

- Previous treatment for glucose

- Body Mass Index =35 kg/m2

- Glycosylated hemoglobin > 6.5%

- Triglycerides =500 mg/dL

- Total cholesterol =240 mg/dL

- Low density lipoprotein (c-LDL) =190 mg/dL

- Blood Pressure =140/90 mmHg



Age minimum: 31 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Prediabetes

Impaired Fasting Glucose

Impaired Glucose Tolerance

Intervention(s)

Dietary Supplement: Berberine

Drug: Metformin

Primary Outcome(s)

Glycosylated hemoglobin [Time Frame: baseline to week 14]

Fasting glucose levels [Time Frame: Baseline to week 14]

Total insulin secretion [Time Frame: baseline to week 14]

First phase of insulin secretion [Time Frame: baseline to week 14]

Insulin sensitivity [Time Frame: baseline to week 14]

postprandial glucose levels [Time Frame: baseline to week 14]

Secondary Outcome(s)

Creatinine levels [Time Frame: Baseline to week 14]

Triglycerides levels [Time Frame: Baseline to week 14]

Aspartate aminotransferase (AST) levels [Time Frame: Baseline to week 14]

Body fat percentage [Time Frame: Baseline to week 14]

Waist circumference [Time Frame: Baseline to week 14]

High density lipoprotein (c-HDL) levels [Time Frame: Baseline to week 14]

Blood pressure [Time Frame: Baseline to week 14]

Body Mass Index [Time Frame: Baseline to week 14]

Total cholesterol [Time Frame: Baseline to week 14]

Alanine aminotransferase (ALT) levels [Time Frame: Baseline to week 14]

Low density lipoprotein (c-LDL) levels [Time Frame: Baseline to week 14]

Body Weight [Time Frame: Baseline to week 14]

Secondary ID(s)

BM-Prediabetes

Source(s) of Monetary Support

Please refer to primary and secondary sponsors