type 2 diabetes mellitus
Conditions
Interventions
The intervention group takes Supersynbiotics LBG-P(Lactobacillus,Bifidobacterium 3.0g/day and oligosaccharide 20.4g/day) for 24 weeks.
The control group continues current therapy and takes no synbioti
Sponsors
Juntendo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) type 2 diabetes at outpatient clinic at Juntendo University Hospital 2) age 30-79 years old 3) gender male and female 4) patients with diet/exercise therapy only or treated by medicines except alpha-glucosidase inhibitor 5) HbA1c(NGSP) 6.0% and over, but less than 9.0% 6) body mass index 25 and over
Exclusion criteria
Exclusion criteria: 1) liver cirrhosis and renal failure (including hemodialysis and serum creatinine 1.5mg/dL and over) 2) type 1 diabetes 3) inflammatory bowel disease 4) past history of digestive surgery 5) milk allergy 6) not suitable for the study (irregular visit)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of change in IL-6 from 0 to 24 weeks after synbiotics administration between the two groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparisons of the following parameters between the two groups 1) changes in plasma LBP and C-reactive protein from 0 to 24 weeks 2) total bacterial counts and its detection rate in blood and feces 3) changes in fecal organic acids, fasting blood glucose, liver function, renal function, C-peptide index 4) Analysis of diversity of gut microbiota using next generation sequencer | — |
Countries
Japan
Contacts
Public ContactAkio Kanazawa
Juntendo University Graduate School of Medicine Department of Metabolism & Endocrinology
Outcome results
None listed