Randomised Placebo-controlled Study of FMT to Impact Body Weight and Glycemic Control in Obese Subjects With T2DM
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| ClinicalTrials.gov Identifier: NCT03127696 |
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Recruitment Status :
Recruiting
First Posted : April 25, 2017
Last Update Posted : February 28, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type2 Diabetes Type 2 Diabetes Mellitus Obese | Procedure: Fecal Microbiota Transplantation Behavioral: Lifestyle Modification Program Procedure: Sham | Not Applicable |
There is a worldwide epidemic of obesity and type 2 diabetes mellitus. The prevalence of obesity and type 2 diabetes mellitus continues to rise at an alarming rate. Weight loss is associated with reductions in risk of morbidity and mortality from obesity. Conventional non-pharmacological interventions based on diet and exercise showed limited long-term success in producing sustained weight loss. Although obese patients with type 2 diabetes mellitus may be treated by medications or by bariatric surgery, these alternatives are limited by incomplete resolution of the diseases, high cost or potential surgical-related morbidity. Further research focusing on increasing effectiveness of interventions and new ways to achieve weight loss in these individuals are needed.
Recently, accumulating evidence supports a role of the enteric microbiota in the pathogenesis of obesity-related insulin resistance. Obesity is associated with changes in the composition of the intestinal microbiota, and the obese microbiome appears to be more efficient in harvesting energy from the diet. Colonization of germ-free mice with an 'obese microbiota' results in a significantly greater increase in total body fat than colonization with a 'lean microbiota', suggesting gut microbiota as an additional contributing factor to the pathophysiology of obesity. Obese and lean phenotypes can also be induced in germ-free mice by transfer of fecal microbiota from human donors. These data have led to the use of microbiota therapeutics as a potential treatment for metabolic syndrome and obesity.
Clinical trials are being conducted to evaluate its use for other conditions. Early results in human have shown that FMT from lean donor when transplanted into subjects with metabolic syndrome resulted in a significant improvement in insulin sensitivity and an increased in intestinal microbial diversity, including a distinct increase in butyrate-producing bacterial strains. The therapy is generally well tolerated and appeared safe. No clinical studies have assessed the efficacy of FMT in obese subjects with type 2 diabetes mellitus.
No clinical studies have assessed the efficacy of FMT in obese subjects with type 2 diabetes mellitus.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomised Placebo-controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Obese Subjects With Type 2 Diabetes Mellitus |
| Actual Study Start Date : | April 26, 2017 |
| Estimated Primary Completion Date : | April 30, 2020 |
| Estimated Study Completion Date : | September 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: FMT + LMP
FMT and lifestyle modification program
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Procedure: Fecal Microbiota Transplantation
FMT Behavioral: Lifestyle Modification Program Lifestyle |
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Experimental: FMT alone
Fecal Microbiota Transplantation
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Procedure: Fecal Microbiota Transplantation
FMT |
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Sham Comparator: Sham + LMP
Sham and lifestyle modification program
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Behavioral: Lifestyle Modification Program
Lifestyle Procedure: Sham Sham |
- Proportion of at least 5% reduction in weight [ Time Frame: 24 weeks ]Determine the proportion of at least 5% reduction in weight compared with baseline weight at week 24
- Proportion of subjects achieving at least 5% reduction in weight compared with baseline [ Time Frame: 52 weeks ]Proportion of subjects achieving at least 5% reduction in weight at 52 weeks
- Changes in waist circumference at weeks 24 and 52 compared with baseline [ Time Frame: 24 week and 52 week ]Compare the change in waist circumference among different treatment arms
- At least 5% decrease in waist to hip ratio [ Time Frame: 24 week and 52 week ]Compare the change in waist to hip ratio among different treatment arms
- At least 5% decrease in total body weight [ Time Frame: 24 week and 52 week ]Compare the change in total body weight among different treatment arms
- Changes in body weight to calculate body mass index (BMI) at weeks 24 and 52 compared with baseline [ Time Frame: 24 week and 52 week ]Compare the change in weight to calculate the BMI among different treatment arms
- Changes in biochemical parameters [ Time Frame: 24 week and 52 week ]Compare the change in biochemical parameters among different treatment arms at weeks 24 and 52 compared with baseline
- Change in microbiome of stool (including bacteriome, virome and fungome) [ Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52 ]Compare the change in microbiome of stool (includign bacteriome, virome and fungome) and duration of change before reverting to baseline
- Difference in microbiome (including bacteriome, virome and fungome) compared between subjects who received FMT and LMP only [ Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52 ]Compare the difference in microbiome (including bacteriome, virome and fungome) between subjects of different treatment arms
- Proportion of microbiome (including bacteriome, virome and fungome) derived from recipient, donor or both in subjects who received FMT [ Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52 ]Proportion of microbiome (including bacteriome, virome and fungome) after FMT from different source
- Difference in microbiome (including bacteriome, virome and fungome) compared between subjects who have weight loss and those do not have weight loss [ Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52 ]Compare the difference in microbiome (including bacteriome, virome and fungome) in subjects with and without weight loss
- Microbial factors (including bacteriome, virome and fungome) that are associated with body weight loss [ Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52 ]Identification of microbial factors (including bacteriome, virome and fungome) that are associated with percentage of body weight loss
- Trans-kingdom correlation of microbial engraftment [ Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52 ]Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-70; and
- BMI >=28 kg/m2 and < 45 kg/m2; and
- A diagnosis of Type 2 diabetes mellitus for >=3 months; and
- Written informed consent obtained
Exclusion Criteria:
- Current pregnancy
- Use of any weight loss medications in the preceding 1 year
- Known history or concomitant significant gastrointestinal disorders (including Inflammatory Bowel Disease, current colorectal cancer, current GI infection)
- Known history or concomitant significant food allergies
- Immunosuppressed subjects
- Known history of severe organ failure (including decompensated cirrhosis), inflammatory bowel disease, kidney failure, epilepsy, acquired immunodeficiency syndrome
- Current active sepsis
- Active malignant disease in recent 2 years
- Known contraindications to oesophago-gastro-duodenoscopy (OGD)
- Use of probiotic or antibiotics in recent 3 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127696
| Contact: Amy LI | +852 26373225 | amyli@cuhk.edu.hk | |
| Contact: Whitney TANG | +852 35051519 | whitneytang@cuhk.edu.hk |
| Hong Kong | |
| The Chinese University of Hong Kong | Recruiting |
| Sha Tin, Hong Kong, 000000 | |
| Contact: Siew Chien Ng, PhD 35053996 siewchienng@cuhk.edu.hk | |
| Principal Investigator: | Siew NG, Prof. | Chinese University of Hong Kong |
Publications:
| Responsible Party: | Siew Chien NG, Professor, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT03127696 History of Changes |
| Other Study ID Numbers: |
FMT-DM-RCT study |
| First Posted: | April 25, 2017 Key Record Dates |
| Last Update Posted: | February 28, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Siew Chien NG, Chinese University of Hong Kong:
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Fecal Microbiota Transplant |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Body Weight Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Signs and Symptoms |