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

NCT ID: NCT03029390

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2023-12-31

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.

Detailed Description

A randomized, double-blind, placebo-controlled clinical trial in 28 patients with a diagnosis of prediabetes (IFG and IGT) in accordance with the American Diabetes Association with out treatment.

They will be assigned randomly two groups of 14 patients, one of the groups will receive 850 mg of metformin twice at day (before breakfast and before dinner) and one pill of placebo (before lunch) for 14 weeks. There will be a running period, starting with a dose of 500 mg the first week, the second week increasing to 1000 mg and from the third to the fourteenth week will be a dose of 1500 mg.

The other group will receive 500 mg of berberine three times at day (each one before the mealtime) for14 weeks. There will be a running period, starting with a dose of 850 mg the first week, the second week dose of 850 mg of metformin plus one placebo pill and from the third week to the fourteenth week will be a dose of 1700 mg ( two 850 mg metformin pills) plus one placebo pill.

They will be measured fasting blood glucose, postprandial glucose levels and glycosylated hemoglobin, and will be calculated Area Under Curve of glucose and insulin, total insulin secretion (Insolinogenic index), first-phase of insulin secretion (Strumvoll index) and insulin sensitivity (Matsuda index).

This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentage for qualitative variable. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p≤0.05.

Conditions

Prediabetes; Impaired Fasting Glucose; Impaired Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Berberine hydrochloride

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)

Group Type: EXPERIMENTAL

Berberine

Intervention Type: 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

Metformin

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).

Group Type: EXPERIMENTAL

Metformin

Intervention Type: 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).

Interventions

Berberine

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

Intervention Type: DIETARY_SUPPLEMENT

Metformin

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).

Intervention Type: DRUG

Other Intervention Names

Berberine hydrochloride

Eligibility 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

• Minimum Eligible Age: 31 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Karina Griselda Pérez Rubio

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KARINA GRISELDA PEREZ, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

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

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

BM-Prediabetes

Identifier Type: -

Identifier Source: org_study_id