Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction
Overview
- Phase
- Early Phase 1
- Intervention
- Lactobacillus fermentum D3
- Conditions
- Diabetes type2
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Changes in HOMA-IR
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type2 diabetes in treatment with metformin
- •30 kg/m2≤IMC≤40 kg/m2
- •30-70 years old
- •HOMA-IR \>6
- •Informed consent
Exclusion Criteria
- •psychopathologic alterations that do not permit the adherence to the trial.
- •Diabetes medication different from metformin.
- •History of cholecystectomy.
- •Use of Probiotics, and/or antibiotics in the last 3 months
Arms & Interventions
Probiotics arm
Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214)
Intervention: Lactobacillus fermentum D3
FMT arm
Individuals who receive a FMT in the form of pills with fecal material from a healthy donor.
Intervention: Fecal microbiota transplant (FMT)
Control arm
Individuals who receive a probiotics pill daily of placebo (milk powder)
Intervention: Placebo
Outcomes
Primary Outcomes
Changes in HOMA-IR
Time Frame: Baseline, 12 weeks
Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)
Secondary Outcomes
- Changes in glucose metabolism(Baseline, 12 weeks)
- Changes in gut microbiota(Baseline, 12 weeks)