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

NCT ID: NCT04341571

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-24
• Study Completion Date: 2025-07-31

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.

Detailed Description

A randomized, double-blind controlled clinical trial in 30 patients between 31 to 60 years of age with a diagnosis of prediabetes (IFG 100 a 125 mg/dL, IGT 140 a 199 mg/dL, HbA1c 5.7 a 6.4%) in accordance with the American Diabetes Association without treatment.

Patients with one or more of the following criteria will be excluded: History of liver, kidney or heart disease; systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, HbA1c ≥6.5%, triglycerides ≥ 400 mg/dL, total cholesterol ≥240 mg/dL; pregnancy or lactation; consumption of medications or supplements with effects on glucose levels.

They will be assigned randomly two groups of 15 patients; one of the groups will receive 750 mg of metformin twice at day (before breakfast and dinner) for 13 weeks.

The other group will receive 400 mg of probiotics 1 time at day (before breakfast) and placebo pill (before dinner) for 13 weeks.

They will be measured fasting blood glucose, postprandial glucose levels and glycosylated hemoglobin, and will be calculated area under curve of glucose an 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. Will be used Wilcoxon range test for identification of differences between baseline and final evaluation of each intervention group, Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered satitistical significance p >0.05.

Conditions

PreDiabetes; Impaired Glucose Tolerance; Hyperglycemia; Resistance, Insulin

Study Design

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

Study Groups

Probiotics

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.

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: 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.

Metformin

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

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin capsules, 750 mg, two pere day before breakfast and dinner during 13 weeks.

Homologated to the other intervention.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Metformin

Metformin capsules, 750 mg, two pere day before breakfast and dinner during 13 weeks.

Homologated to the other intervention.

Intervention Type: DRUG

Eligibility 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

• 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

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KARINA G PÉREZ-RUBIO, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

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

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

Probiotics-Prediabetes

Identifier Type: -

Identifier Source: org_study_id