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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Pre diabetes (PD) is a term that refers to alterations in blood glucose levels, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, and increase in glycated hemoglobin (HbA1c), all this factors involving a higher risk to develop type 2 diabetes mellitus (T2DM).

The efficacy of pharmacotherapy in the prevention of diabetes in adults with pre diabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, probiotics administration has been reported to be one of the most widely used approaches to modulate the gut microbiota and subsequently prevent or delay the incidence of T2DM.

Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Has been demonstrated the hypoglycemic effects of the probiotics in different clinical trials in type 2 diabetes mellitus and pre diabetes, but no yet compared with metformin, for this reason comparing it´s activity against metformin in pre diabetes would provide impact information on a new alternative treatment compared with the standard pharmacological treatment.

The aim of the study is evaluate the effect of administration of probiotic versus metformin on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.

• Phase: Phase 2
• 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 ADA criteria (fasting blood glucose levels between 100-125 mg/dL, postprandial blood glucose levels after an oral glucose tolerance test with 75 g of oral glucose between 140-199 mg/dL and glycated hemoglobin between 5.7-6.4 %)

• Body Mass Index from 25 to 34.9 kg/m2

• Stable weight at least the previous last 3 months (weight variation less than 10%)

• Acceptance and signing of informed consent

Exclusion Criteria:

• History of kidney, liver or heart disease

• Women with confirmed or suspected pregnancy

• Women under lactation and/or puerperium

• Physical impossibility for taking pills

• Hypersensibility to ingredients of intervention

• Consumption of medications or supplements with effects on glucose levels

• Systolic blood pressure ≥ 140 mmHg

• Diastolic blood pressure ≥ 90 mmHg

• HbA1c ≥6.5%

• Triglycerides ≥ 400 mg/dL

• Total cholesterol ≥ 240 mg/dL