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

NCT03029390 | Unknown Phase 4

• 1 other identifier: BM-Prediabetes
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Pre diabetes (PD) is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), Imparied glucose tolerance (IGT) or both, involving a higher risk to develop type 2 diabetes mellitus (T2DM) in 10 years. The efficacy of pharmacotherapy in the prevention of diabetes in adults with prediabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, the traditional Chinese and Ayurverica medicine offer potential active substances for the treatment of hyperglucemia like berberine. Berberine is an extract with hypoglycemic effects in animal models as well as in clinical trials in type 2 diabetes mellitus even compared to metformin, for this reason comparing it's activity against metformin in prediabetes would provide impact information on a new alternative treatment and compare with the standard pharmacological treatment. The aim of the study evaluate the effect of administration of berberine versus metaformine on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes. The investigators hypothesis is that the administration of berberine versus metformin modifies glycemic control, insulin sensitivity and insulin secretion in patients with prediabetes.

Conditions

Prediabetes; Impaired Fasting Glucose; Impaired Glucose Tolerance

Keywords

Prediabetes; hyperglycemia; Impaired Fasting Glucose; Metformin; Berberine; glucose intolerance

Outcome Measures

Primary Outcomes (6)

• Fasting glucose levels

  The fasting glucose levels will be evaluated at baseline and week 14 with enzymatic/ colorimetric techniques and the entered values reflect the fasting glucose level at week 14

  Baseline to week 14

• postprandial glucose levels

  Postprandial glucose will be evaluated at baseline week 14 after a oral glucose tolerance test with enzymatic/ colorimetric techniques and the entered values reflect the insulin sensitivity at week 14

  baseline to week 14

• Glycosylated hemoglobin

  Glycosylated hemoglobin will be evaluated at baseline and week 14 by Elisa and the entered values reflect the glycosylated hemoglobin at week 14

  baseline to week 14

• Total insulin secretion

  Total insulin secretion will be calculated at baseline and week 14 with insulinogenic index and the entered values reflect the total insulin secretion at week 14

  baseline to week 14

• First phase of insulin secretion

  The first phase of insulin secretion will be calculated at baseline and week 14 with Strumvoll index and the entered values reflect the first phase of insulin secretion at week 14

  baseline to week 14

• Insulin sensitivity

  Insulin sensitivity will be calculated at baseline and week 14 with Matsuda index and the entered values reflect the insulin sensitivity at week 14

  baseline to week 14

Secondary Outcomes (12)

• Body Weight

  Baseline to week 14

• Body Mass Index

  Baseline to week 14

• Body fat percentage

  Baseline to week 14

• Waist circumference

  Baseline to week 14

• Blood pressure

  Baseline to week 14

Study Arms (2)

Berberine hydrochloride

EXPERIMENTAL

Berberine capsules, 500 mg, three per day before each meal during 12 weeks. The patients will have a forced titration period: First week they will receive one 500 mg capsule before breakfast Second week they will receive two 500 mg capsules (before breakfast and meal) From the third week until the end of the study, they will be receive three 500 mg capsules (before each meal)

Dietary Supplement: Berberine

Metformin

EXPERIMENTAL

Metformin capsules, 850 mg, two per day before breakfast and dinner and one placebo capsule before lunch during 12 weeks. The patients will have a forced titration period: First week they will receive one 850 mg capsule before breakfast Second week they will receive one 500 mg capsules (before breakfast) and one placebo capsule (before meal). From the third week until the end of the study, they will be receive two 850 mg capsules (before breakfast and dinner) and one placebo capsule (before meal).

Drug: Metformin

Interventions

Berberine DIETARY_SUPPLEMENT

Berberine capsules, 500 mg, three per day before each meal during 14 weeks. The patients will have a running period during two weeks: First week they will receive one 500 mg capsule before breakfast Second week they will receive two 500 mg capsules (before breakfast and meal) From the third week until the end of the study (14 week), they will be receive three 500 mg

Also known as: Berberine hydrochloride

Berberine hydrochloride

Metformin DRUG

Metformin capsules, 850 mg, two per day before breakfast and dinner and one placebo capsule before lunch during 14 weeks. The patients will have a running period: First week they will receive one 850 mg capsule before breakfast Second week they will receive one 500 mg capsules (before breakfast) and one placebo capsule (before meal). From the third week until the end of the study (14 week), they will be receive two 850 mg capsules (before breakfast and dinner) and one placebo capsule (before meal).

Metformin

Eligibility Criteria

• Age: 31 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance; Hyperglycemia

Interventions

Berberine; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• KARINA GRISELDA PEREZ, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: March 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: December 1, 2023
• Last Updated: May 23, 2023

Record last verified: 2022-06

Locations

ME (1)