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

NCT04341571 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-27

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotics

Probiotics capsules (lactobacillus acidophilus y bifidobacterium lactis) 400 mg 1 time at day before breakfast and one placebo capsule before dinner during 13 weeks. Homologated to the other intervention.

DRUG

Metformin

Metformin capsules, 750 mg, two pere day before breakfast and dinner during 13 weeks. Homologated to the other intervention.

Sponsors & Collaborators

  • University of Guadalajara

    lead OTHER

Principal Investigators

  • KARINA G PÉREZ-RUBIO, PhD · University of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
31 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-24
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Mexico

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04341571 on ClinicalTrials.gov