Smectite Gel and Probiotic for Obesity and Insulin Resistance

NCT04293731 | Completed

• 1 other identifier: ENDO-6
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Smectite is a natural silicate clay belonging to the dioctahedral smectite class formed from aluminomagnesium silicate. It is not absorbed from the gastrointestinal tract, but binds to intestinal mucous, forms multilayer structure with high plastic viscosity and powerful coating properties hence preserving integrity of the mucus, and has the ability to absorb directly bacterial toxins, bacteria, viruses and bile salts. The current study aim was to conduct placebo-controlled randomize clinical trial for the efficiency of a combination of multiprobiotics with smectite (Symbiter-Forte formulation) as an adjunction to the standard anti-diabetic therapy on IR, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response in type 2 diabetes patients.

Conditions

Obesity; Insulin Resistance; Insulin Sensitivity; Type2 Diabetes Mellitus; Visceral Obesity

Keywords

Smectite; Probiotic; Lactobacillus; Bifidobacterium; Propionibacterium; Acetobacter; Obesity; Type2 Diabetes; Insulin Resistance

Outcome Measures

Primary Outcomes (2)

• HOMA-2IR

  This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php

  8 weeks compared to baseline

• insulin sensitivity (%S)

  This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php

  8 weeks compared to baseline

Secondary Outcomes (8)

• HbA1c

  8 weeks compared to baseline

• fasting plasma glucose (FPG)

  8 weeks compared to baseline

• β-cell function (%B)

  8 weeks compared to baseline

• C-peptide

  8 weeks compared to baseline

• weight

  8 weeks compared to baseline

Study Arms (2)

Symbiter-Smectite

ACTIVE COMPARATOR

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

Dietary Supplement: Symbiter-Smectite

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Symbiter-Smectite DIETARY_SUPPLEMENT

Symbiter-Smectite contains biomass of alive probiotic microorganism symbiosis, colony forming units - CFU/g: Lactobacillus - 1.0х109, Bifidobacterium - 1.0х109, Lactococcus - 1.0х108, Propionibacterium - 1.0х108 and Acetobacter - 1.0х105; and smectite gel (250 mg)

Symbiter-Smectite

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 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)
• presence of type 2 diabetes diagnosed according to criteria of the American Diabetes Association (fasting plasma glucose (FPG)≥7.0mmol/l, random plasma glucose ≥11.1mmol/l, HbA1c ≥6.5%, or glucose higher than 11.1mmol/l 2 hours after a 75-g oral glucose load);
• type 2 diabetes duration 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-2IR≥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;
• allergy on probiotics or their components;
• presence of gastrointestinal diseases such as food allergy, celiac disease, non-specific ulcerative colitis;
• 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
• Taras Shevchenko National University of Kyiv: collaborator

Study Sites (1)

Bogomolets National Medical University

Kyiv, 01601, Ukraine

Location

Related Publications (1)

• Kobyliak N, Abenavoli L, Falalyeyeva T, Kovalchuk O, Kyriienko D, Komisarenko I. Metabolic Benefits of Probiotic Combination with Absorbent Smectite in type 2 Diabetes Patients a Randomised Controlled Trial. Rev Recent Clin Trials. 2021;16(1):109-119. doi: 10.2174/1574887115666200709141131.

  PMID: 32646362 RESULT

MeSH Terms

Conditions

Obesity; Insulin Resistance; Obesity, Abdominal

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Nazarii Kobyliak, PhD

  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, Endocrinology Department

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 3, 2020
• Study Start: November 1, 2018
• Primary Completion: May 25, 2019
• Study Completion: May 28, 2019
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)