Type2 Diabetes Clinical Trial
Official title:
Effect of Probiotic Co-administration With Omega-3 Fatty Acids on NAFLD: Randomized Clinical Studies
NCT number | NCT03528707 |
Other study ID # | ENDO-2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 14, 2015 |
Est. completion date | January 28, 2016 |
Verified date | December 2019 |
Source | Bogomolets National Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
One of the potential ideal strategy for NAFLD treatment may be manipulation with gut microbiota. Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Omega-3 fatty acids belong to the family of polyunsaturated fatty acids. They are known to exert a strong positive influence on metabolism and inflammation. The data from animal studies suggested that both probiotics and omega-3 can affect body weight, influence on glucose and fat metabolism, improve insulin sensitivity and reduce chronic systemic inflammation. In respect to experimental data, the current study aim was to provide double-blind single center RCT, for study the efficacy of co-administration of probiotic with omega-3 vs. placebo in type 2 diabetes patient with NAFLD detected on ultrasonography
Status | Completed |
Enrollment | 48 |
Est. completion date | January 28, 2016 |
Est. primary completion date | December 22, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - adult participants (ages 18-75, BMI =25 kg/m2) diagnosed with NAFLD according to the recommendations of the American Gastroenterology Association (AGA) and American Association for the Study of Liver Disease (AASLD); - the diagnosis of fatty liver was based on the results of abdominal ultrasonography. Of 4 known criteria (hepato-renal echo contrast, liver brightness, deep attenuation, and vascular blurring), the participants were required to have hepato-renal contrast and liver brightness to be given a diagnosis of NAFLD. - type 2 diabetes treated with diet and exercise alone or metformin, SUs and insulin at stable dose at least 4 weeks prior to the commencement of the study; - AST and ALT =3x upper limit of normal. Exclusion Criteria: - alcohol abuse (>20 g/day (2 standard drinks) in women or > 30 g/d (3 drinks) in men over a two-year period); - chronic viral hepatitis (associated with HBV, HCV, HDV infection); - drug-induced liver disease, Wilson's disease, hereditary deficiency of antitrypsin-1 and idiopathic hemochromatosis; - history of decompensated liver disease including ascites, encephalopathy or variceal bleeding; - 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, active malignancy, or chronic infections; - use of agents such as vitamin E, omega-3 fatty acids or medications with evidence for effects on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid); - and presence of active infection, pregnancy or lactation. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bogomolets National Medical University |
Kobyliak N, Abenavoli L, Falalyeyeva T, Mykhalchyshyn G, Boccuto L, Kononenko L, Kyriienko D, Komisarenko I, Dynnyk O. Beneficial effects of probiotic combination with omega-3 fatty acids in NAFLD: a randomized clinical study. Minerva Med. 2018 Dec;109(6) — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fatty liver index (FLI) | FLI = [e 0.953*loge (triglycerides) + 0.139*BMI + 0.718*loge (ggt) + 0.053*waist circumference - 15.745) / (1 + e 0.953*loge (triglycerides) + 0.139*BMI + 0.718*loge (ggt) + 0.053*waist circumference - 15.745)] × 100 | 8 weeks compared to baseline | |
Primary | liver stiffness (LS) | liver stiffness (LS) was measured by Shear Wave Elastography (SWE) and expressed in kPa. | 8 weeks compared to baseline | |
Secondary | ALT | ALT in IU/L | 8 weeks compared to baseline | |
Secondary | AST | AST in IU/L | 8 weeks compared to baseline | |
Secondary | ?-GT | ?-GT in IU/L | 8 weeks compared to baseline | |
Secondary | Total Cholesterol (TC) | TC in mmol/l | 8 weeks compared to baseline | |
Secondary | Tryglicerides (TG) | TG in mmol/l | 8 weeks compared to baseline | |
Secondary | LDL-Cholesterol (LDL-C) | LDL-C in mmol/l | 8 weeks compared to baseline | |
Secondary | VLDL-Cholesterol (VLDL-C) | VLDL-C in mmol/l | 8 weeks compared to baseline | |
Secondary | HDL-Cholesterol (HDL-C) | HDL-C in mmol/l | 8 weeks compared to baseline | |
Secondary | cytokines levels | TNF-a, IL-1ß, IL-6, IL-8, INF-? in pg/ml | 8 weeks compared to baseline |
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