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Effect of Probiotic on Insulin Resistance in Type 2 Diabetes Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434860
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Nazarii Kobyliak, Bogomolets National Medical University

Brief Summary:
Probiotics have beneficial effect on obesity related disorders in animal models. Despite a large number of animal data, randomized placebo-controlled trials (RCT) concluded that probiotics have a moderate effect on glycemic control-related parameters. However, effect of probiotics on insulin resistance are inconsistent. In this double-blind single center RCT, effect of alive multistrain probiotic vs. placebo on insulin resistance in type 2 diabetes patient will be assessed.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Insulin Resistance Probiotic Dietary Supplement: probiotic Dietary Supplement: placebo Not Applicable

Detailed Description:

In this single-center double blind, placebo controlled, parallel group study, type 2 diabetes patients from the Kyiv City Clinical Endocrinology Center will be selected. They will be randomly assigned to receive multiprobiotic "Symbiter" or placebo for 8-weeks administered as a sachet formulation in double-blind treatment. Randomization will be done by the study statistician based on a computer-generated list. The groups will be homogeneous according to age, sex and diagnostic criteria. The assignment of groups will be blind to participants, research staff and outcome assessors moreover, to maintain blind parallel study the statistician was not aware of the allocation of participants to intervention.

The multiprobiotic "Symbiter" will be supplied by Scientific and Production Company "O.D. Prolisok". It contains of 14 alive probiotic strains of Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g) genera. Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of probiotic and placebo per day. All sachets were identical with similar organoleptic characteristics (e.g., taste and appearance).

The pre-randomization period designed to minimize the effects of dietary changes on metabolic markers. For this purpose, 2 weeks before the study start, after inform consent signed, patients will be instructed in one-on-one sessions with a dietitian to follow a therapeutic lifestyle-change diet as classified by the NCEP. In addition, participants will be instructed to continue with stable anti-hyperglycemic treatment and received standardized mild physical training for 1 hour per day.

Patients who underwent study will be instructed to take the trial medication as prescribed. Throughout the study, weekly phone follow-up visits will be provided for assessment of compliance, adherence to the protocol, as well as the recording of adverse events. The effectiveness of therapy will be compared and evaluated separately in the two groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Randomization was done by the study statistician based on a computer-generated list. The groups were homogeneous according to age, sex and diagnostic criteria. The assignment of groups was blind to participants, research staff and outcome assessors moreover, to maintain blind parallel study the statistician was not aware of the allocation of participants to intervention
Primary Purpose: Treatment
Official Title: Effect of Alive Multistrain Probiotic on Insulin Resistance in Type 2 Diabetes Patients
Actual Study Start Date : January 15, 2016
Actual Primary Completion Date : November 20, 2016
Actual Study Completion Date : January 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: probiotic
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) per day.
Dietary Supplement: probiotic
The multiprobiotic "Symbiter" which contains of 14 alive probiotic strains of Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g) genera. Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of probiotic per day.

Placebo Comparator: placebo
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) per day.
Dietary Supplement: placebo
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day




Primary Outcome Measures :
  1. HOMA-IR [ Time Frame: 8 weeks compared to baseline ]
    HOMA-IR was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 8 weeks compared to baseline ]
    HbA1c in %

  2. fasting plasma insulins (FPI) [ Time Frame: 8 weeks compared to baseline ]
    FPI in microU/L

  3. fasting plasma glucose (FPG) [ Time Frame: 8 weeks compared to baseline ]
    FPG in mmol/L

  4. weight [ Time Frame: 8 weeks compared to baseline ]
    weight in kg

  5. waist circumferences (WC) [ Time Frame: 8 weeks compared to baseline ]
    WC in cm

  6. body mass index (BMI) [ Time Frame: 8 weeks compared to baseline ]
    weight and height will be combined to report BMI in kg/m^2

  7. cytokines levels [ Time Frame: 8 weeks compared to baseline ]
    TNF-α, IL-1β, IL-6, IL-8, INF-γ



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult participants (ages 18-75, BMI ≥25 kg/m2) diagnosed with T2D according WHO (1999) for at least 6 months prior to the study;
  • patient who treated with diet and exercise alone or metformin, SUs and insulin on a stabilized dose for at least 3 months before the study;
  • presence of insulin resistance established as HOMA-IR≥2.0;
  • HbA1c between 6.5 and 11.0 %;
  • written informed consent.

Exclusion Criteria:

  • presence of type 1 diabetes;
  • treatment with other than mention in inclusion criteria antidiabetic drugs (pioglitazone, GLP-1 analogues, DPP IV inhibitors etc);
  • regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment;
  • antibiotic use within 3 months prior to enrollment;
  • uncontrolled cardiovascular or respiratory disease, decompensated liver disease including ascites, encephalopathy or variceal bleeding, active malignancy, or chronic infections;
  • participation in other clinical trials;
  • presence of pregnancy or lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434860


Sponsors and Collaborators
Bogomolets National Medical University
Investigators
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Principal Investigator: Petro Bodnar, Prof Bogomolets National Medical University
Publications of Results:
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Responsible Party: Nazarii Kobyliak, Associate Professor of Endocrinology Department, PhD, Bogomolets National Medical University
ClinicalTrials.gov Identifier: NCT03434860    
Other Study ID Numbers: ENDO-4
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism