Brief Summary

The incidence of obesity has dramatically increased during the last three decades, leading to a significant increase of obesity-related morbidity, including type 2 diabetes mellitus (T2DM) that is characterized by resistance of target tissues to insulin action. T2DM obese patients may be treated by medications or by bariatric surgery. Both alternatives have limitations due to incomplete resolution of the diseases, high cost or potential procedural related morbidity. An increasing body of evidence points to a role of the enteric microbiota in the pathogenesis of obesity-related insulin resistance. In addition to that, the gut microbiota is directly affected by the diet composition. Studies in T2DM mice carrying human gut germs, demonstrated special interactions between the gut microbiota and the host, creating a typical microbiota composition which changes significantly following diet change from a western diet, rich with sugar, to a vegetarian diet rich with fibers. This rapid alternations in the microbiota composition has also shown in humans, after changing from western to high fiber diet. A change in diet life style may lead to an improvement in T2DM symptoms such as decrease in visceral adipose tissue.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2015

Completed

19 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed

1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed

Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

January 8, 2015

Last Update Submit

June 8, 2016

Conditions

Diabetes Mellitus, Type 2 Obesity

Keywords

MicrobiotaDiabetes Mellitus, Type 2Obesity

Outcome Measures

Primary Outcomes (2)

30% decrease in insulin resistance
Lean donor FMT will result in 30% decrease in insulin resistance that will be further enhanced after a second FMT. These will be meditated by an alteration of intestinal microbiota
6 weeks after first FMT
40% decrease in insulin resistance compared to baseline
12 weeks after second FMT

Secondary Outcomes (4)

Decreased use of diabetes medications
Week 6 and 12 post FMT
Improvement in anthropometric measures and in metabolic indices
week 6 and 12 post FMT
Maintenance of an improved insulin resistance
28 weeks post FMT
Maintenance of altered of enteric microbiota in the three diet groups
6, 12, 28 weeks post FMT

Study Arms (3)

FMT from a lean donor+ high fat diet

ACTIVE COMPARATOR

Patients will undergo FMT (Fecal Microboita Transplantation) from a lean donor twice during study through a gastroscopy: 1. at time 0 2. after 6 weeks Patient will start high fat low fiber diet 2 weeks before first FMT and continue on consuming the same diet 9 weeks after the first FMT. Patient will be followed up by a nutritionist through the the study.

Procedure: gastroscopyDrug: Fecal Microbiota TransplantationOther: high fat low fiber diet

FMT from a lean donor+ sham diet

SHAM COMPARATOR

Patients will undergo FMT (Fecal Microboita Transplantation) from a lean donor twice during study through a gastroscopy: 1. at time 0 2. after 6 weeks Patient will start sham diet (no change in fat/fiber consumption) 2 weeks before first FMT and continue on consuming the same diet 9 weeks after the first FMT. Patient will be followed up by a nutritionist through the the study.

Procedure: gastroscopyDrug: Fecal Microbiota TransplantationOther: sham diet

FMT from lean donor+ low fat diet

ACTIVE COMPARATOR

Patients will undergo FMT (Fecal Microboita Transplantation) from a lean donor twice during study through a gastroscopy: 1. at time 0 2. after 6 weeks Patient will start low fat high fiber diet 2 weeks before first FMT and continue on consuming the same diet 9 weeks after the first FMT. Patient will be followed up by a nutritionist through the the study.

Procedure: gastroscopyDrug: Fecal Microbiota TransplantationOther: low fat high fiber diet