Obesity Clinical Trial
Official title:
Effect of Probiotic Lysate (Postbiotic and Metabiotic) Supplementation on Metabolic Parameters in Type 2 Diabetes Patients
Verified date | April 2024 |
Source | Bogomolets National Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - presence of type 1 diabetes; - severe diabetes-related complications at screening (ie, end-stage DKD, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy); - treatment with other than mention in inclusion criteria antidiabetic drugs (pioglitazone, SGLT-2 antagonists, GLP-1 analogues, DPP IV inhibitors etc); - 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. |
Country | Name | City | State |
---|---|---|---|
Ukraine | Bogomolets National Medical University | Kyiv | |
Ukraine | Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine | Kyiv | |
Ukraine | Kyiv City Clinical Endocrinology Center | Kyiv | |
Ukraine | Danylo Halytsky Lviv National Medical University | Lviv |
Lead Sponsor | Collaborator |
---|---|
Bogomolets National Medical University | Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine, Danylo Halytsky Lviv National Medical University, Kyiv City Clinical Endocrinology Center, MirImmunoFarm, Stellar Biotics, Taras Shevchenko National University of Kyiv |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in HbA1c level | HbA1c in % | at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline | |
Primary | 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 | 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 | at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline | |
Secondary | 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
[Time Frame: 8 weeks compared to baseline] |
at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline | |
Secondary | ß-cell function (%B) | 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
[Time Frame: 8 weeks compared to baseline] |
at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline | |
Secondary | C-peptide | C-peptide, ng/ml | at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline | |
Secondary | High censitivity CRP (C-reactive Protein) | hs-CRP in mg/L | at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline | |
Secondary | weight | weight in kg | at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline | |
Secondary | waist circumferences (WC) | WC in cm | at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline | |
Secondary | body mass index (BMI) | weight in kg and height in meters will be combined to report BMI in kg/m^2 | at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline |
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