In order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a Lactobacillus fermentum D3 in pills daily; 2) FMT arm, who will take a lyophilized fecal microbiota transplant in pills; and 3) control group, who will take placebo pills. After 3 months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
22
Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.
Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.
Placebo in a white, gelatin capsule (orally), with powder milk
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Changes in HOMA-IR
Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)
Time frame: Baseline, 12 weeks
Changes in gut microbiota
Change from baseline in 16S rRNA amplicons after 3 months
Time frame: Baseline, 12 weeks
Changes in glucose metabolism
Change from baseline in oral glucose tolerance test (OGTT)
Time frame: Baseline, 12 weeks
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