Diabetes Mellitus, Type 2Phase 2NCT02346669
Fecal Microbiota Transplantation for Diabetes Mellitus Type II in Obese Patients
A Phase 2 study testing gastroscopy, Fecal Microbiota Transplantation and high fat low fiber diet in people with Diabetes Mellitus, Type 2 and Obesity, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- gastroscopy, Fecal Microbiota Transplantation and high fat low fiber diet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30≤BMI
- A diagnosis of T2DM (≥3 months) and one of the following:
- Fasting glucose level≥126mg/dL and/ or
- A stable dose of anti-diabetic drugs for ≥2 weeks and/or
- HbA1C≥6.5
- Access to a smart phone supporting the research application for tracking food consumption.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Gastroentherology
Tel Aviv, 64239
Nitsan Maharshak, MD, 972-3-6972488, nitsanm@tlvmc.gov.il
Nitsan Maharshak, MD
About this study
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.
Read the detailed description
Study design:
30 Patients will undergo 2 FMT's from a lean donor and will be randomized into 3 types of diet groups:
- low fat high fiber diet (20% fat)
- no change in fat intake (sham diet)
- 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.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- gastroscopy, Fecal Microbiota Transplantation, high fat low fiber diet, sham diet, low fat high fiber diet
- Keywords
- Microbiota, Diabetes Mellitus, Type 2, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastroscopyProcedure or surgery
as detailed in arm description
Fecal Microbiota TransplantationDrug
as detailed in arm description
high fat low fiber dietOther
as detailed in arm description
sham dietOther
as detailed in arm description
low fat high fiber dietOther
as detailed in arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: gastroscopy; Drug: Fecal Microbiota Transplantation; Other: 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. Receives: Procedure: gastroscopy; Drug: Fecal Microbiota Transplantation; Other: 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. Receives: Procedure: gastroscopy; Drug: Fecal Microbiota Transplantation; Other: low fat high fiber diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks after first FMT
40% decrease in insulin resistance compared to baseline
Measured: 12 weeks after second FMT
Secondary outcomes (4)
Decreased use of diabetes medications
Measured: 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
Measured: 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.
Measured: 28 weeks post FMT
Maintenance of altered of enteric microbiota in the three diet groups
Measured: 6, 12, 28 weeks post FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startApr 2016
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nitsan Maharshak, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346669
- Sponsor's protocol ID
- TASMC-14-NM-447-CTIL
- Status last verified
- Jun 2016
- First submitted
- 8 Jan 2015
- Last updated
- 9 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Diabetes Mellitus Type II in Obese Patients
- ClinicalTrials.gov ID
- NCT02346669
- Acronym / sponsor ID
- TASMC-14-NM-447-CTIL
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- Microbiota, Diabetes Mellitus, Type 2, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Apr 2016
- Primary completion
- Jan 2018 (estimated)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design:
30 Patients will undergo 2 FMT's from a lean donor and will be randomized into 3 types of diet groups:
- low fat high fiber diet (20% fat)
- no change in fat intake (sham diet)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FMT from a lean donor+ high fat diet | Active comparator | Procedure: gastroscopy, Drug: Fecal Microbiota Transplantation, Other: high fat low fiber dietPatients 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. |
| FMT from a lean donor+ sham diet | Sham comparator | Procedure: gastroscopy, Drug: Fecal Microbiota Transplantation, Other: sham dietPatients 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. |
| FMT from lean donor+ low fat diet | Active comparator | Procedure: gastroscopy, Drug: Fecal Microbiota Transplantation, Other: low fat high fiber dietPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastroscopyas detailed in arm description | Procedure or surgery | FMT from a lean donor+ high fat diet, FMT from a lean donor+ sham diet, FMT from lean donor+ low fat diet |
| Fecal Microbiota Transplantationas detailed in arm description | Drug | FMT from a lean donor+ high fat diet, FMT from a lean donor+ sham diet, FMT from lean donor+ low fat diet |
| high fat low fiber dietas detailed in arm description | Other | FMT from a lean donor+ high fat diet |
| sham dietas detailed in arm description | Other | FMT from a lean donor+ sham diet |
| low fat high fiber dietas detailed in arm description | Other | FMT from lean donor+ low fat diet |
Primary outcome
30% decrease in insulin resistance
Time frame: 6 weeks after first FMT
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
40% decrease in insulin resistance compared to baseline
Time frame: 12 weeks after second FMT
4 secondary outcomes
Decreased use of diabetes medications
Time frame: Week 6 and 12 post FMT
Improvement in anthropometric measures and in metabolic indices
Time frame: week 6 and 12 post FMT
Maintenance of an improved insulin resistance
Time frame: 28 weeks post FMT
Maintenance of altered of enteric microbiota in the three diet groups
Time frame: 6, 12, 28 weeks post FMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitsan Maharshak, MD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gastroscopy, Fecal Microbiota Transplantation and high fat low fiber diet in people with Diabetes Mellitus, Type 2 and Obesity, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitsan Maharshak, MD (972-3-6972488, nitsanm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30% decrease in insulin resistance (time frame: 6 weeks after first FMT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.