Epigenetic and Microbiota Modifications

Study Overview
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Brief Summary
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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.

Official Title
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Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction

Conditions
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Diabetes type2, Obesity

Intervention / Treatment
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* Dietary Supplement: Lactobacillus fermentum D3
* Biological: Fecal microbiota transplant (FMT)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics arm<br>Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214) | Dietary Supplement: Lactobacillus fermentum D3<br>* Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.<br>* Other names: PCT/EP 2012058214;|
| Experimental: FMT arm<br>Individuals who receive a FMT in the form of pills with fecal material from a healthy donor. | Biological: Fecal microbiota transplant (FMT)<br>* Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.<br>|
| Placebo Comparator: Control arm<br>Individuals who receive a probiotics pill daily of placebo (milk powder) | Drug: Placebo<br>* Placebo in a white, gelatin capsule (orally), with powder milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HOMA-IR | Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5) | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gut microbiota | Change from baseline in 16S rRNA amplicons after 3 months | Baseline, 12 weeks | 
| Changes in glucose metabolism | Change from baseline in oral glucose tolerance test (OGTT) | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes type2, FMT, Probiotics, Microbiota