Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Study design:
30 Patients will undergo 2 FMT's from a lean donor and will be randomized into 3 types of diet groups:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| 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:
|
|
| 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gastroscopy | Procedure | as detailed in arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Decreased use of diabetes medications | Week 6 and 12 post FMT | |
| Improvement in anthropometric measures and in metabolic indices | At least 5% decrease in waist to hip ratio and in total body weight |
Not provided
Inclusion Criteria:
30≤BMI
A diagnosis of T2DM (≥3 months) and one of the following:
Access to a smart phone supporting the research application for tracking food consumption.
Exclusion Criteria:
Patients will also be excluded if:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nitsan Maharshak, MD | Contact | 972-3-6972488 | nitsanm@tlvmc.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Nitsan Maharshak, MD | Tel Aviv Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroentherology | Recruiting | Tel Aviv | 64239 | Israel |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005773 | Gastroscopy |
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fecal Microbiota Transplantation | Drug | as detailed in arm description |
|
| high fat low fiber diet | Other | as detailed in arm description |
|
| sham diet | Other | as detailed in arm description |
|
| low fat high fiber diet | Other | as detailed in arm description |
|
| week 6 and 12 post FMT |
| 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 |
| Maintenance of altered of enteric microbiota in the three diet groups | 6, 12, 28 weeks post FMT |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |