Epigenetic and Microbiota Modifications

Obesity Clinical Trial

— EPI-MICROBIO  

Official title:

Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076656
• Other study ID #: EPIGEN-MICROBIOTA
• Status: Completed
• Phase: Early Phase 1
• Start date: June 10, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2021
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 30, 2022
• Est. primary completion date: October 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes type2
• Obesity

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Victoria	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in gut microbiota	Change from baseline in 16S rRNA amplicons after 3 months	Baseline, 12 weeks
Secondary	Changes in glucose metabolism	Change from baseline in oral glucose tolerance test (OGTT)	Baseline, 12 weeks