Epigenetic and Microbiota Modifications

Overview

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.

Full Title of Study: “Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2021

Interventions

  • Dietary Supplement: Lactobacillus fermentum D3
    • Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.
  • Biological: Fecal microbiota transplant (FMT)
    • Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.
  • Drug: Placebo
    • Placebo in a white, gelatin capsule (orally), with powder milk

Arms, Groups and Cohorts

  • Experimental: Probiotics arm
    • Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214)
  • Experimental: FMT arm
    • Individuals who receive a FMT in the form of pills with fecal material from a healthy donor.
  • Placebo Comparator: Control arm
    • Individuals who receive a probiotics pill daily of placebo (milk powder)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Francisco J Tinahones, MD, PhD, Principal Investigator, Instituto de Investigación Biomédica de Málaga (IBIMA).
  • Overall Contact(s)
    • Francisco J Tinahones, MD, PhD, +34 951032647, fjtinahones@uma.es

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