Fecal Microbiota Transplantation for Diabetes Mellitus Type II in Obese Patients

Obesity Clinical Trial

Official title:

Fecal Microbiota Transplantation for Diabetes Mellitus Type II in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02346669
• Other study ID #: TASMC-14-NM-447-CTIL
• Status: Recruiting
• Phase: Phase 2
• First received: January 8, 2015
• Last updated: June 8, 2016
• Start date: April 2016

Study information

• Verified date: June 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nitsan Maharshak, MD
• Phone: 972-3-6972488
• Email: nitsanm[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Study design:

30 Patients will undergo 2 FMT's from a lean donor and will be randomized into 3 types of diet groups:

1. low fat high fiber diet (20% fat)

2. no change in fat intake (sham diet)

3. high fat low fiber diet (40-45% fat)

The treating physicians and the patients will be blinded for the diet arm. Before and after FMT, patients will be assessed after an overnight fast (and before taking medications) for weight, anthropometric measures, questionnaires (dietary, general health, antibiotic and probiotic exposure, oral diabetes medication quantity, and other drug exposure), blood and stool.

The investigators hypothesize that fecal microbial transplantation from a lean donor to T2DM obese patients, with the combination of low fat high fiber diet, will alter the gut microbiota composition to decrease insulin resistance through microbiota dependent metabolic and immunologic effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 30=BMI

• A diagnosis of T2DM (=3 months) and one of the following:

1. Fasting glucose level=126mg/dL and/ or

2. A stable dose of anti-diabetic drugs for =2 weeks and/or

3. HbA1C=6.5

• Access to a smart phone supporting the research application for tracking food consumption.

Exclusion Criteria:

• participation in other clinical trial

• incapable of signing an informed consent

• pregnancy or breast feeding

• Antibiotic treatment within the prior 3 months or predicted antibiotic treatment

• insulin medications

• drugs or alcohol addiction

• immune mediated diseases

• type 1 diabetes and latent autoimmune diabetes of adults

• systemic disease

• ischemic heart disease

• probiotics consumption

• a new or unstable treatment with anti diabetic medications

Patients will also be excluded if:

• treated by systemic antibiotic during the study

• will not be compliant with the diet

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Procedure:
• gastroscopy
as detailed in arm description

Drug:
• Fecal Microbiota Transplantation
as detailed in arm description

Other:
• high fat low fiber diet
as detailed in arm description
• sham diet
as detailed in arm description
• low fat high fiber diet
as detailed in arm description

Locations

Country	Name	City	State
Israel	Department of Gastroentherology	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	40% decrease in insulin resistance compared to baseline		12 weeks after second FMT	No
Secondary	Decreased use of diabetes medications		Week 6 and 12 post FMT	No
Secondary	Improvement in anthropometric measures and in metabolic indices	At least 5% decrease in waist to hip ratio and in total body weight	week 6 and 12 post FMT	No
Secondary	Maintenance of an improved insulin resistance	Insulin resistance at 28 weeks will be in the range (+5% to -5%) of the value achieved at week 12.	28 weeks post FMT	No
Secondary	Maintenance of altered of enteric microbiota in the three diet groups		6, 12, 28 weeks post FMT	No