The Effect of a Multistrain Probiotic on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study

Poznan University of Physical Education

Status: Completed

Conditions: Insulin Resistance

Treatments: Dietary Supplement: the group GS (probiotic); Dietary Supplement: the group GP (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT06092060

PoznanUPhyEd Probiotyk

Details and patient eligibility

About

The goal of this study is to evaluate the efficacy of metformin on insulin sensitivity and vascular endothelial function with respect to gut microbiota and metabolome in women with established insulin resistance and its tolerance after 12 weeks of probiotic therapy.

The hypothesis is probiotic therapy in women with established insulin resistance undergoing metformin treatment increases the drug's efficacy to improve insulin sensitivity and intestinal endothelial function, and reduces gastrointestinal side effects.

Study participants will be randomly assigned to 2 groups, taking a probiotic (GS) or a placebo (GP). The randomization scheme will be computer-generated using permuted blocks of block size 4.

Enrollment: 40 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women 25-45 years old, menstruating, BMI 25-32.9 kg / m2, insulin resistance based on the HOMA-IR index (cut-off point 2.5

Exclusion criteria

• type 1 and 2 diabetes,
• poorly controlled arterial hypertension (mean SBP values> 140mmHg and / or mean DBP values> 90mmHg) within the last month and / or the need to modify pharmacological treatment,
• 2nd degree obesity, BMI> 35 kg / m2,
• lipid disorders requiring pharmacological treatment in the last 3 months before the start of observation or during observation,
• positive history of ischemic heart disease, carotid and / or lower limb atherosclerosis,
• features of heart failure on physical examination and / or additional examinations (chest X-ray, echocardiography),
• clinically significant arrhythmias or conduction disturbances,
• chronic kidney disease with creatinine clearance <60mL / min / 1.73m2,
• clinically significant impairment of liver function (transaminase values 3 times the normal range),
• acute or chronic, clinically evident inflammatory process (diseases of connective tissue and joints, inflammatory processes of the respiratory tract, inflammatory processes of the genitourinary system, inflammation of the head and neck),
• acute infection in the last month,
• Cancer,
• alcohol abuse, drug addiction,
• taking medications that may interfere with test results,
• Taking antibiotics, steroids, antifungal and antiparasitic agents 4 weeks before the examination (not applicable to topical antifungal agents).
• taking pre - and / or probiotics in the last 12 weeks before the test
• travel to tropical countries in the last 4 weeks prior to the survey
• other conditions that may pose any risk to the patient during the follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

the group GS

Experimental group

Description:

probiotic treatment group, ca. 20 participants

Treatment:

Dietary Supplement: the group GS (probiotic)

the group GP

Placebo Comparator group

Description:

placebo group, ca. 20 participants

Treatment:

Dietary Supplement: the group GP (placebo)