Clinical trial NCT06092060: 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
Official title: The Effect of a Multi-strain Probiotic Consisting of: Bifidobacterium Lactis W52, Lactobacillus Brevis W63, Lactobacillus Casei W56, Lactococcus Lactis W19, Lactococcus Lactis W58, Lactobacillus Acidophilus W37, Bifidobacterium Bifidum W23, Bifidobacterium Lactis W51, and Lactobacillus Salivarius W24 on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Insulin Resistance
Multistrain Probiotic
Gut Microbiota
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Qualitative assessment of intestinal microbiota in stool samples
timeFrame: up to 10 months
measure: Quantitive change in intestinal microbiota in stool samples
timeFrame: up to 10 months
measure: Intestinal metabolome in stool samples
timeFrame: up to 10 months
measure: Indicators of insulin sensitivity and carbohydrate metabolism
timeFrame: up to 10 months
measure: Evaluation of indicators in stool
timeFrame: up to 10 months
measure: Indicators of lipid metabolism
timeFrame: up to 10 months
measure: Transcription factors regulating carbohydrate and lipid metabolism
timeFrame: up to 10 months
measure: Adipokines and myokines
timeFrame: up to 10 months
measure: Indicators of inflammation
timeFrame: up to 10 months
measure: Indicators of vascular endothelial function
timeFrame: up to 10 months
measure: Indicators of a disrupted intestinal barrier in the blood
timeFrame: up to 10 months
Secondary outcomes:
measure: Gastrointestinal disorders questionnaire
timeFrame: up to 10 months
measure: Body mass analysis (BMI, kg/m^2)
timeFrame: up to 10 months
measure: Body composition analysis (percent of total body mass
timeFrame: up to 10 months
measure: Composite measure of Diet composition assessed by food diaries
timeFrame: up to 10 months
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Physical Education
Study officials:
affiliation: Poznan University of Physical Education
name: Joanna Karolkiewicz, Prof
role: PRINCIPAL_INVESTIGATOR
References: