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

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04341571
• Other study ID #: Probiotics-Prediabetes
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 24, 2019
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Hyperglycemia
• Impaired Glucose Tolerance
• Insulin Resistance
• PreDiabetes
• Prediabetic State
• Resistance, Insulin

Intervention

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.

Locations

Country	Name	City	State
Mexico	INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Glycosylated hemoglobin	Glycosylated hemoglobin will be evaluated at baseline and week 13 by high efficiency liquid chromatography.	Baseline to week 13 (end of intervention)
Primary	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)
Primary	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)
Primary	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	Body weight	Body weight will be measured at baseline and week 13 with a bioimpedance balance	Baseline to week 13 (end of intervention)
Secondary	Body mass index (BMI)	Body mass index will be calculated at baseline and week 13 with the Quetelet index formula	Baseline to week 13 (end of intervention)
Secondary	Waist circunference	Waist circunference will be evaluated at baseline and week 13 by World Health Organization technique	Baseline to week 13 (end of intervention)
Secondary	Blood pressure	Systolic blood pressure and diastolyc blood pressure will be measured at baseline and week 13 with a digital sphygmomanometer three times in each arm to get an average	Baseline to week 13 (end of intervention)
Secondary	Total cholesterol	Total chilesterol level will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get total cholesterol level	Baseline to week 13 (end of intervention)
Secondary	High density lipoprotein (c-HDL)	High density lipoprotein (c-HDL) level will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get c-HDL level	Baseline to week 13 (end of intervention)
Secondary	Low density lipoprotein (c-LDL)	Low density lipoprotein (c-LDL) level will be calculated at baseline and week 13 with Friedewald formula to get c-LDL level	Baseline to week 13 (end of intervention)
Secondary	Very low density lipoprotein (VLDL)	Very low density lipoprotein (VLDL) level will be calculated at baseline and week 13 with triglycerides concentration/5 formula to get VLDL level	Baseline to week 13 (end of intervention)
Secondary	Fasting blood triglycerides concentration	Fasting blood triglycerides concentration level will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get triglycerides concentration	Baseline to week 13 (end of intervention)
Secondary	Concentration of blood creatinine	Concentration of blood creatinine level will be evaluated at baseline and week 13 by enzymatic-colorimetric technique to get creatinine level	Baseline to week 13 (end of intervention)
Secondary	Concentration of blood alanine aminostranferase (ALT)	Concentration of blood alanine aminostranferase level will be evaluated at baseline and week 13 by enzymatic-colorimetric technique to get ALT level	Baseline to week 13 (end of intervention)
Secondary	Concentration of blood aspartate aminostranferase (AST)	Concentration of blood aspartate aminostranferase level will be evaluated at baseline and week 13 by enzymatic-colorimetric technique to get AST level	Baseline to week 13 (end of intervention)
Secondary	Incidence of treatment-Emergent Adverse Events	Incidence of treatment-Emergent Adverse Events of probiotics+placebo or metformin will be identified by clinical evaluation from baseline week to week 13 with continuous surveiilance	Baseline to week 13 (continuous surveiilance)