Insulin Resistance Clinical Trial
Official title:
Effect of Alive Multistrain Probiotic on Insulin Resistance in Type 2 Diabetes Patients
Verified date | December 2019 |
Source | Bogomolets National Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | January 25, 2017 |
Est. primary completion date | November 20, 2016 |
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 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. Exclusion Criteria: - presence of type 1 diabetes; - treatment with other than mention in inclusion criteria antidiabetic drugs (pioglitazone, GLP-1 analogues, DPP IV inhibitors etc); - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Bogomolets National Medical University |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | HbA1c | HbA1c in % | 8 weeks compared to baseline | |
Secondary | fasting plasma insulins (FPI) | FPI in microU/L | 8 weeks compared to baseline | |
Secondary | fasting plasma glucose (FPG) | FPG in mmol/L | 8 weeks compared to baseline | |
Secondary | weight | weight in kg | 8 weeks compared to baseline | |
Secondary | waist circumferences (WC) | WC in cm | 8 weeks compared to baseline | |
Secondary | body mass index (BMI) | weight and height will be combined to report BMI in kg/m^2 | 8 weeks compared to baseline | |
Secondary | cytokines levels | TNF-a, IL-1ß, IL-6, IL-8, INF-? | 8 weeks compared to baseline |
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