None listed
Conditions
Brief summary
There is growing evidence that gut microbiota is involved in the pathogenesis of type 2 diabetes mellitus. In humans, there is very little data on the effect of gut microbiota transfer on glucose metabolism. The objective of this study is to examine the feasibility of performing colonic faecal microbiota transplantation (FMT) in overweight pre-diabetic/diabetic adults and any potential metabolic effects of altering human colonic microbiota on insulin sensitivity.
Interventions
A group of overweight adults with pre-diabetes or diet-controlled diabetes will be randomised to receive a faecal microbial transplant (FMT) from either a lean healthy donor or their own gut microbiota. The donated faeces will be homogenised with 500 mL of normal saline in a blender and all of the 500 mL will be infused via colonoscopy into the colon of the recipient. The colonoscopy will take approximately 20 minutes and will be performed by a gastroenterologist. Measurements of weight, HbA1c,
A group of overweight adults with pre-diabetes or diet-controlled diabetes will be randomised to receive a faecal microbial transplant (FMT) from either a lean healthy donor or their own gut microbiota. The donated faeces will be homogenised with 500 mL of normal saline in a blender and all of the 500 mL will be infused via colonoscopy into the colon of the recipient. The colonoscopy will take approximately 20 minutes and will be performed by a gastroenterologist. Measurements of weight, HbA1c, fasting glucose and insulin, and oral glucose tolerance test will be performed at regular intervals post-FMT to determine effect of gut microbiota transfer on weight and glucose metabolism. No specific strategies to monitor adherence are required.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility criteria will be: Body mass index (BMI) of 25 kg/m2 or greater. Aged 18 years or above. Fasting blood glucose >6.0 mmol/L or HbA1c >40 mmol/mol Not taking any glucose lowering medications
Exclusion criteria
Anyone lacking mental capacity to provide informed consent. Prebiotic/probiotic supplements or antibiotics in the last 3 months. Past cholecystectomy.
Outcome results
None listed