Probiotic Lactobacillus Reuteri DSM 17938 for Glucose Metabolism Improvement in Type 2 Diabetes Patients
This study aims to evaluate if the probiotic Lactobacillus Reuteri DSM 17938 can improve glucose metabolism and insulin sensitivity in adults with type 2 diabetes, as measured by the HOMA index over a 12-week period.
Lactobacillus reuteri DSM 17938
Diabetes Mellitus+5
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: May 1, 2012
Actual date on which the first participant was enrolled.Recent data suggest that the trillions of bacteria in the investigators gastrointestinal tracts (gut microbiota) can function as an environmental factor that modulates the amount of body fat. Obese individuals have an altered gut microbiota and germ-free mice are resistant to developing diet-induced obesity and have lower fasting insulin and glucose and improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus strain in fermented milk for 12 weeks reduced adiposity and body weight in obese adults, possibly by reducing lipid absorption and inflammatory status. However, there are no studies to the investigators knowledge that address whether probiotic supplementation improves glucose metabolism in type 2 diabetes patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 50 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Type 2 diabetes with a duration \> 6 months * Abdominal obesity * HbA1c 50-80 mmol/mol * Written informed consent * Stated availability throughout the study period Exclusion Criteria: * Autoimmune diabetes eg type 1 diabetes * Psychiatric illness or cancer diagnosis * No foreseeable need of treatment with corticosteroids or antibiotics * Inflammatory bowel disease * Administration of antibiotics 4 weeks before inclusion * Administration of probiotics 2 weeks before inclusion * Participation in other clinical trials
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Gothia Forum, CTC, Gröna Stråket 12, Sahlgrenska University Hospital
Gothenburg, SwedenOpen Gothia Forum, CTC, Gröna Stråket 12, Sahlgrenska University Hospital in Google Maps