Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Type 2 Diabetes Patients (DELI_Diab Study)

NCT05770076 | Completed

• 1 other identifier: DELI_Diab
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

Brief Summary

The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on insulin resistance, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response in type 2 diabetes patients. The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month.

Conditions

Obesity; Obesity, Abdominal; Insulin Resistance; Insulin Sensitivity; Type2 Diabetes; Type 2 Diabetes Mellitus in Obese

Keywords

Postbiotics; metabiotics; L. rhamnosus; L. delbrueckii; Obesity; Type2 Diabetes; Insulin Resistance

Outcome Measures

Primary Outcomes (2)

• Changes in HbA1c level

  HbA1c in %

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline

• Changes in fasting plasma glucose (FPG) level

  FPG in mmol/L

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline

Secondary Outcomes (8)

• HOMA-2IR

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline

• insulin sensitivity (%S)

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline

• β-cell function (%B)

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline

• C-peptide

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline

• High censitivity CRP (C-reactive Protein)

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline

Study Arms (2)

Probiotic lysate (postbiotic and metabiotic) group

ACTIVE COMPARATOR

oral, 2 capsules per day (BID) for 3 month treatment

Dietary Supplement: Probiotic lysate (postbiotic and metabiotic)

Placebo group

PLACEBO COMPARATOR

placebo, oral, 2 capsules per day (BID) for 3 month treatment

Dietary Supplement: Placebo

Interventions

Probiotic lysate (postbiotic and metabiotic) DIETARY_SUPPLEMENT

Each capsule contains 100 mg of cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023 in powder

Also known as: Del-Immune V® Extra

Probiotic lysate (postbiotic and metabiotic) group

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult participants (ages 18-70)
• presence of T2D diagnosed according to criteria of the American Diabetes Association;
• BMI 25-40 kg/m2;
• 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;
• daily insulin dosage less than 60IU;
• HbA1c between 6.5 and 10.0 %;
• written informed consent.

You may not qualify if:

• presence of type 1 diabetes;
• severe diabetes-related complications at screening (ie, end-stage DKD, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy);
• regular use of an agents with gut microbiota modulation activity (antibiotic, pro-, pre-, post or synbiotics supplement etc.) 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;
• participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks prior to enrollment;
• participation in other clinical trials;
• presence of pregnancy or lactation.

Sponsors & Collaborators

• Bogomolets National Medical University: lead
• Taras Shevchenko National University of Kyiv: collaborator
• Danylo Halytsky Lviv National Medical University: collaborator
• Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine: collaborator
• Kyiv City Clinical Endocrinology Center: collaborator
• MirImmunoFarm: collaborator
• Stellar Biotics: collaborator

Study Sites (4)

Bogomolets National Medical University

Kyiv, 01601, Ukraine

Location

Kyiv City Clinical Endocrinology Center

Kyiv, 01601, Ukraine

Location

Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine

Kyiv, 02000, Ukraine

Location

Danylo Halytsky Lviv National Medical University

Lviv, 79010, Ukraine

Location

MeSH Terms

Conditions

Obesity; Obesity, Abdominal; Insulin Resistance

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 3, 2023
• First Posted: March 15, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

UA (4)