Effect of Probiotic on Insulin Resistance in Type 2 Diabetes Patients

NCT03434860 | Completed

• 1 other identifier: ENDO-4
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes; Insulin Resistance; Probiotic

Outcome Measures

Primary Outcomes (1)

• HOMA-IR

  HOMA-IR was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5

  8 weeks compared to baseline

Secondary Outcomes (7)

• HbA1c

  8 weeks compared to baseline

• fasting plasma insulins (FPI)

  8 weeks compared to baseline

• fasting plasma glucose (FPG)

  8 weeks compared to baseline

• weight

  8 weeks compared to baseline

• waist circumferences (WC)

  8 weeks compared to baseline

Study Arms (2)

probiotic

ACTIVE COMPARATOR

Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) per day.

Dietary Supplement: probiotic

placebo

PLACEBO COMPARATOR

Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) per day.

Dietary Supplement: placebo

Interventions

probiotic DIETARY_SUPPLEMENT

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.

probiotic

placebo DIETARY_SUPPLEMENT

Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• presence of type 1 diabetes;
• 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.

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Related Publications (1)

• Kobyliak N, Falalyeyeva T, Mykhalchyshyn G, Kyriienko D, Komissarenko I. Effect of alive probiotic on insulin resistance in type 2 diabetes patients: Randomized clinical trial. Diabetes Metab Syndr. 2018 Sep;12(5):617-624. doi: 10.1016/j.dsx.2018.04.015. Epub 2018 Apr 10.

  PMID: 29661605 RESULT

MeSH Terms

Conditions

Insulin Resistance

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Petro Bodnar, Prof

  Bogomolets National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endocrinology Department, PhD

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: February 15, 2018
• Study Start: January 15, 2016
• Primary Completion: November 20, 2016
• Study Completion: January 25, 2017
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share