Last updated 21 months ago
Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus
80 patients around the world
Available in Brazil
The purpose of this study is to evaluate the effect of multispecies probiotic supplementation
(specifically designed for the present study) on fecal microbiota, nutritional status,
metabolic and inflammatory parameters in patients with type 2 diabetes mellitus (T2DM).
Adult individuals (35 to 75 years old) of both sexes with T2DM (diagnosed at least 1 year
ago), body mass index from 25.00 kg/m² to 39.99 kg/m², glycated hemoglobin ≤ 9.0% and using
metformin will be invited to participate in this randomized, placebo-controlled, triple-blind
study.
The participants will be randomized into two groups: G1 - probiotic group and G2 - control
group (placebo).
The study will consist of two experimental time points: M0 - baseline and start of
supplementation; M1 - after 12 weeks of the first outpatient visit and start of
supplementation.
In the two experimental moments, individual fecal samples will be obtained for analysis of
the fecal microbiota; The metabolic parameters will be assessed by determination of
circulating levels of SCFA, FFA, insulin, fasting glucose and glycated hemoglobin, HOMA-IR;
Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; the inflammatory response
will be assessed by determination of plasma indicadors (LPS, Adiponectina, IL-10, IL-1, IL-6,
TNF- α, Leptina, Resistina) ; besides the evaluation of indicators of nutritional status
(bone densitometry with body composition and anthropometric measurements).
The primary endpoint will be the fecal microbiota composition, SCFA concentrations and the
inflammatory parameters.
Universidade Federal de Santa Catarina
1Research sites
80Patients around the world
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- Age from 35 to 75 years old;Individuals diagnosed with type 2 diabetes mellitus (at least 1 year ago);Body mass index from 25.00 kg/m² to 39.99 kg/m²;Glycated hemoglobin ≤ 9.0% ;Using metformin, combined or not with other antidiabetic drugs
- Previous bowel diseases (inflammatory bowel disease and irritable bowel syndrome); or previous gastrointestinal surgery (eg, colectomy, gastrectomy)Intolerances and ∕ or food allergies with a previous medical diagnosis (eg lactose intolerance or celiac disease);Glomerular filtration rate <30 ml/min/1.73m²; inflammatory diseases and immunodeficiencies;Diagnosis of autonomic neuropathy with gastrointestinal involvement such as: diabetic gastroparesis, diabetic enteropathy (diarrhea) or colonic hypomotility (constipation);Hospital admission and/or use of anti-inflammatory drugs (non-hormonal and corticosteroids) up to 1 month before the study; and ∕or use of antibiotics up to 3 months before the study;Regular use of laxatives, opioid narcotic analgesics or appetite suppressants;Current or previous use (up to 1 month) of prebiotics, probiotics, symbiotics or products enriched with these food supplements;Intolerance to prebiotics, probiotics or symbiotics;Pregnant or breastfeeding;Follow-up of a diet, guided by a nutritionist, for weight loss or gain up to 1 month before the study or current follow-up of unusual diets (eg vegetarian, macrobiotic, paleolithic);Alcohol consumption (> 1 drink/day or 14g of alcohol for women; >2 drinks/day or 28 grams of alcohol for men); use of illicit drugs and smokers;Change of lipid-lowering and/or antidiabetic drugs in the last 3 months
Sites
Polydoro Ernani de São Thiago University Hospital
Recruiting
SponsorUniversidade Federal de Santa Catarina
Study typeInterventional
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05418179
