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

• Status: Active, not recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Insulin; Metformin

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