Type 2 Diabetes
Conditions
Keywords
lactobacillus reuteri, type 2 diabetes
Brief summary
The purpose of this study is to evaluate the efficacy and safety of probiotics ADR-1/GMNL-263 capsules (Lactobacillus reuteri ADR-1/ Lactobacillus reuteri GMNL-263) for the treatment of adults with type2 DM.
Detailed description
Background：Based on animal studies, intake of probiotic bacteria was suggested to improve insulin sensitivity by reducing inflammation. Objective ： The objective of this study was to determine the effects of supplementation with the probiotic strain Lactobacillus reuteri ADR-1(ADR-1) and Lactobacillus reuteri GMNL-263 (GMNL-263) over six months on metabolic profiles, intestinal microbiota profiles and biomarkers of inflammation in type 2 diabetes patents. Methods ： This randomized double-blind placebo-controlled clinical trial was performed on 120 diabetic patients. Subjects were divided into 3 groups: 40 subjects in the group A received placebo, 40 subjects in the group B received ADR-1 (4 x 109 colony-forming units/d), and 40 subjects in the group C received GMNL-263. (2 x 1010 cells/d) for 6 months. Fasting blood samples were taken at baseline and after intervention to measure metabolic profiles and biomarkers of inflammation including C reactive protein (CRP), Interleukin 6 (IL-6) and Tumor necrosis factor-alpha( TNF-α). The intestinal microbiota profiles were detected in stool samples by real-time polymerase chain reaction (RT-PCR).
Interventions
OTHERADR-1
two ADR-1 capsules, once daily, QD
OTHERGMNL-263
two GMNL-263 capsules, once daily, QD
OTHERplacebo
two placebo capsules, once daily, QD
Sponsors
GenMont Biotech Incorporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes with a duration\> 6 months 2. 7 % \< HbA1c ≦ 10 % 3. Adults 25- 70 years of age 4. BMI\>18.5
Exclusion criteria
1. Pregnancy 2. Subjects with any other serious diseases such as cancer (patient with benign tumor under medical control should not be ruled out), kidney failure / dialysis, heart disease, stroke. 3. Autoimmune Disease 4. Administration of other healthy food for diabetes 4 weeks before inclusion 5. Administration of probiotic 4 weeks before inclusion 6. Administration of antibiotics 4 weeks before inclusion 7. Participation in other clinical trials 8. ALT/SGPT or AST/SGOT \> 3x upper limit of normal (ULN) 9. eGFR\<30mL/min/1.73m2 10. Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood sugar | 6 months | Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure blood sugar(mg/dL) and HbA1c(%). |
| Change in blood fat | 6 months | Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure cholesterol(mg/dL) ,triglycerides(TG, mg/dl), high density lipoprotein (HDL, mg/dl), low density lipoprotein (LDL, mg/dl). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the DM marker | 6 months | Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure insulin(μIU/mL), C-peptide(ng/mL), Homeostasis model assessment for insulin resistance (HOMA-IR, ratio) |
Countries
Taiwan
Outcome results
None listed