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

NCT04341571 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: Probiotics-Prediabetes
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

PreDiabetes; Hyperglycemia; Resistance, Insulin; Impaired Glucose Tolerance

Keywords

Probiotics; Prediabetes; Hyperglycemia; Impaired Fasting Glucose; Glucose intolerance; Metformin

Outcome Measures

Primary Outcomes (6)

• Fasting glucose levels

  The fasting glucose levels will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get fasting glucose level

  Baseline to week 13 (end of intervention)

• Postpandrial glucose levels

  Glucose will be evaluated at baseline and week 13 after a oral glucose tolerance test with enzymatic-colorimetric technique

  Baseline to week 13 (end of intervention)

• Glycosylated hemoglobin

  Glycosylated hemoglobin will be evaluated at baseline and week 13 by high efficiency liquid chromatography.

  Baseline to week 13 (end of intervention)

• Insulin sensitivity

  Insulin sensitivity will be calculated at baseline and week 13 with Matsuda index to get insuline sensitivity

  Baseline to week 13 (end of intervention)

• Total insulin secretion

  Total insulin secretion will be calculated at baseline and week 13 with Insulinogenic index to get total insulin secretion

  Baseline to week 13 (end of intervention)

• First phase of insuline secretion

  The first phase if insuline secretion will be calculated at baseline and week 13 with Stumvoll index to get first phase of insuline secretion

  Baseline to week 13 (end of intervention)

Secondary Outcomes (13)

• Body weight

  Baseline to week 13 (end of intervention)

• Body mass index (BMI)

  Baseline to week 13 (end of intervention)

• Waist circunference

  Baseline to week 13 (end of intervention)

• Blood pressure

  Baseline to week 13 (end of intervention)

• Total cholesterol

  Baseline to week 13 (end of intervention)

Study Arms (2)

Probiotics

EXPERIMENTAL

15 patients to receive homologated intervention capsule (probiotics lactobacillus acidophilus y bifidobacterium lactis 400 mg) 1 time at day before breakfast along 13 weeks and receive 1 homologated placebo capsule (calcinated magnesia 500 mg) 1 time at day before dinner along 13 weeks.

Dietary Supplement: Probiotics

Metformin

EXPERIMENTAL

15 patients to receive homologated intervention capsule (metformin 750 mg) twice at day before breakfast and dinner for 13 weeks.

Drug: Metformin

Interventions

Probiotics DIETARY_SUPPLEMENT

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.

Probiotics

Metformin DRUG

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

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance; Hyperglycemia; Insulin Resistance

Interventions

Probiotics; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• KARINA G PÉREZ-RUBIO, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blind, controlled clinical trial

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: October 24, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

ME (1)