Type 2 Diabetes MellitusPhase 2SETOMNCT05253768
Safety and Efficacy of Human Microbiota Transplantation for Overweight and Obese Type 2 Diabetes Mellitus
A Phase 2 study testing Fecal microbiota transplant (FMT) and normal saline and glycerin/food coloring in people with Type 2 Diabetes Mellitus and Overweight and Obesity, run by Zhujiang Hospital at 1 site in China.
Trial summary
The main purpose is to evaluate whether the percentage of body weight change from baseline to week 12 is higher than that in the placebo group. In this randomized, double-blind, placebo-controlled study, 39 patients fulfilling the study criteria will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Overweight and Obesity
- What is being tested?
- Fecal microbiota transplant (FMT) and normal saline and glycerin/food coloring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- Mar 2024to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of T2DM (≥2 months) according to the dagnostic and typing criteria of Chinese guideline for type 2 diabetes
- Control the blood glucose level through diet or exercise only and never receive any hypoglycemic agent in the last 8 weeks.
- Continuous treatment with insulin and its analogues for no more than 14 days in the last year. (The duration of treatment with insulin and its analogues for gestational diabetes mellitus is not included)
- 7.0%≤HbA1c≤10.0%
- Fasting plasma glucose(FPG)<15mmol/L
- 24kg/m2≤BMI≤35kg/m2
- Give informed consent and agree to receive FMT
- Agree to maintain the same diet and exercise habit during the whole process.
Who cannot join
- 1. Diagnosed with T1D, gestational diabetes mellitus(GDM) or other special type of diabetes.
- 2. The presence of any of the following medical histories or clinical conditions that the investigator believes the risks of participation in the study outweigh the benefits or the treatment of combined conditions that may affect subject compliance or the objectivity of the study outcomes.
- Patients with gastrointestinal disease(such as Irritable bowel syndrome, inflammatory bowel disease, peptic ulcer, gastrointestinal bleeding history, etc.) or history of gastrointestinal surgery(such as gastrectomy, gastroenterostomy, bowel resection, etc.) and are assessed to be unsuitable to participate in this clinical trial by researchers.
- Patients with severe diabetic complications (diabetic ketoacidosis, hyperglycemic hyperosmolar condition etc.) in the last 6 months.
- Patients in unstable condition and need therapy for proliferative diabetic retinopathy or maculopathy, severe diabetic neuropathy, diabetic foot or intermittent claudication in the last 6 months.
- Patients with severe kidney diseases and liver diseases or systemic diseases of other viscera.
Show all 35Show fewer
- History or condition of following heart disease in the last 6 months
- Decompensated cardiac insufficiency(graded III or IV in NYHA)
- History of unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation
- Diagnosed with Severe arrhythmias requiring treatment(like long QT syndrome etc.), and assessed to be unsuitable to participate in this clinical trial by researchers
- Patients with uncontrolled hypertension (systolic blood pressure (SBP) ≥ 160mmHg or diastolic blood pressure (DBP) ≥ 100mmHg at screening time).
- Diagnosed with hemorrhagic stroke or ischemia stroke in the last 6 months and assessed to be unsuitable to participate in this clinical trial by researchers.
- History of other severe endocrine system diseases that affect glucose metabolism or body weight, such as multiple endocrine adenomas, acromegaly syndrome, Cushing's syndrome, and hyperthyroidism and assessed to be unsuitable to participate in this clinical trial by researchers.
- History of malignant tumor in the last 5 years (cured basal cell carcinoma of the skin and carcinoma in situ of the cervix are excluded) or malignant tumor being assessed.
- Patients who have psychiatric disorders or language disorders or are unable or reluctant to communicate, cooperate and be followed up or may have difficulty completing the study judged by the investigator.
- Patients with severe infection or trauma or history of major surgery in the last 3 months and assessed to be unsuitable to participate in this clinical trial by researchers.
- History of substance abuse in the last five years, including repeated and large use of dependent medication which is unrelated to medical purposes (addiction medicine and habitual medicine which can lead to physical and mental dependence are included).
- HIV, TP and HBsAg positive.
- Participated in any clinical trials of interventional medication or devices in the last 3 months.
- Patients with anemia or patients who need regular blood transfusion treatment.
- 3. Receive any of the following medications or treatments.
- Self-reported weight changes of more than 5kg or use of medication which may result in weight-gain or weight-loss including diuretic, weight loss medicine and so on in the last 90 days.
- Use of antibiotics in the last 12 weeks.
- Patients who have used drugs that may affect blood glucose for more than 1 week in the last 12 weeks, such as oral/intravenous glucocorticoid growth hormone, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc. (usage of low-dose diuretics (hydrochlorothiazide < 25mg/d, indapamide ≤1.5mg/d) for antihypertensive purposes are not included).
- Consumption of food or preparation like yogurt, fermented foods, dietary supplements (fish oil, probiotics, prebiotics, various microorganisms, minerals, nutritional foods or herbal preparations) and so on which can affect the gut microbiota in the last 4 weeks.
- Previous or planned bariatric surgery.
- 4. Laboratory results during the screening period meet the following criteria.
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 upper limit of normal.
- Glomerular filtration rate(eGFR)< 60 mL/min/1.73m2 calculated by CKD-EPI.
- Hemoglobin <100g/L
- Proteinuria 2+ or above.
- 5. Patients who have suspected or confirmed history of alcohol or drug abuse.
- 6. Patients known to be allergic to the FMT or its accessories.
- 7. Pregnancy, breast-feeding, or plans to become pregnant.
- 8. Patients who are assessed to be unsuitable to participate in this clinical trial by researchers for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: Safety and Efficacy of Human Microbiota Transplantation for Overweight and Obese Type 2 Diabetes Mellitus ( SETOM ): A Randomized, Double-blind, Placebo-controlled Clinical Study
The main purpose is to evaluate whether the percentage of body weight change from baseline to week 12 is higher than that in the placebo group.
In this randomized, double-blind, placebo-controlled study, 39 patients fulfilling the study criteria will be enrolled in the study. Patients will be randomized(2:1) to either FMT or placebo.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study evaluating fecal microbiota transplantation from lean healthy donors to reduce the patients' weight. Patients wishing to participate will be evaluated whether they qualify for the study regarding the aforementioned inclusion and exclusion criteria. The details of the experiment and potential risks or discomforts involved in it will be presented, after which the patients will sign informed consent forms.
In this study, patients will be randomly assigned to the experimental group and the control group in a 2:1 ratio according to a random allocation table. The table will be formulated on the basis of the random numbers generated by SPSS.
The study will comprise of three parts:
- Baseline - two weeks of run-in and screening period.
- Ensure that each patient reads and signs informed consent.
- Collect demographic data.
- Ask about past medical history, current medical history, surgical history, allergy history, etc.
- Ask about previous medication and combination medication.
- Complete the FFQ questionnaire.
- Collect information about vital signs, physical examination, BMI, ECG, conventional index and therapeutic effect index.
- Collect 2 tubes of stool samples for fecal metagenomics sequencing and three tubes of blood samples for measuring serum metabolomics and inflammatory index (IL-6).
- Review whether patients qualify for participate in the study according to the inclusion and exclusion criteria.
- Dietitian will give diet, exercise lifestyle intervention guidance to patients.
- FMT/ placebo intervention-patients will receive three interventions every two weeks. Four donors of any gender will be recruited for this study. Patients will receive 200ml FMT from donors with the same gender or receive the same amount of placebo FMT. FMT will be packaged in a 50ml sterile syringe or in an enema bag/surgical nutrition bag, the outer package of which will be affixed with the unique identifiable bar code label generated according to the biological specimen bank of the Department of Laboratory Medicine. The placebo FMT will be mainly composed of normal saline and glycerin and will be packaged in the same way as FMT. The night before receiving FMT or placebo FMT via nasointestinal tube, patients will go through proton pump inhibitors(oral 20mg esomeprazole or 40mg omeprazole). The end of the nasointestinal tube should reach at least the patient's duodenum, or reach the patient's jejunum if the patient cooperate. To prevent aspiration, the patient's upper body must maintain an upright posture of 45 degrees for 4 hours after the infusion. Before the first intervention, information about drug combination, vital signs, physical examination, BMI, body composition analysis and adverse events of patients will be collected, and advice of diet and lifestyle will be given to patients. Before the second intervention and before the third intervention, information about drug combination, vital signs, physical examination, BMI, renal function, liver function, blood fat, fasting blood glucose/C-peptide/insulin, body composition analysis and adverse events of patients will be collected, and advice of diet and lifestyle will be given to patients.
- Follow-up meetings - total follow up of 6 weeks after FMT/placebo intervention. Meetings will occur 2 weeks and 6 weeks after the third intervention.
During every follow-up meeting, information about drug combination, vital signs, physical examination, BMI, inflammatory biomarkers, renal function, liver function, blood fat, HbAlc, fasting blood glucose/C-peptide/insulin, 2-hour postprandial blood glucose/C-peptide/insulin, body composition analysis and adverse events of patients will be collected, and advice of diet and lifestyle will be given to patients. In the second follow-up meeting, there will be a fecal metagenomics sequencing and a serum metabonomics analysis.
- Conditions
- Type 2 Diabetes Mellitus, Overweight and Obesity
- Being tested
- Fecal microbiota transplant (FMT), normal saline and glycerin/food coloring
- Keywords
- Fecal Microbiota Transplantation(FMT), Type 2 Diabetes Mellitus, obesity, Weight Loss, Diabetes Mellitus, Overweight
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Weight Loss, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplant (FMT)Biological
Patients will randomized to a fecal microbiota transplantation by using a nasointestinal tube for 3 times in 4 weeks(0,2,4) without undergoing an enema before the treatment.
The amount of FMT is 200ml at one time. Patients are given the same lifestyle guidance and nutritional advice.
normal saline and glycerin/food coloringOther
Patients will receive an equivalent volume of normal saline and glycerin/food coloring via a nasointestinal tube (sham transplantation) for 3 times in 4 weeks(0,2,4) without undergoing an enema before the treatment.
The amount of placebo FMT is 200ml at one time. Patients are given the same lifestyle guidance and nutritional advice.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Patients who receive a fecal microbiota transplantation via a nasointestinal tube. Receives: Biological: Fecal microbiota transplant (FMT) |
| placebo | Placebo comparator | Patients who receive a placebo FMT via a nasointestinal tube. Receives: Other: normal saline and glycerin/food coloring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of change in weight compared with baseline.
Measured: 12 weeks
Secondary outcomes (26)
The absolute value of change in weight compared with baseline.
Measured: 6,12 weeks
Proportion of at least 5% reduction in weight.
Measured: 12 weeks
Proportion of at least 10% reduction in weight.
Measured: 12 weeks
Proportion of at least 15% reduction in weight.
Measured: 12 weeks
Proportion of patients with HbA1c < 7.0%.
Measured: 12 weeks
Proportion of patients with HbA1c < 6.5%.
Measured: 12 weeks
Change in the level of HbA1c.
Measured: 6,12 weeks
Change in FCP (fasting C-peptide) compared with baseline.
Measured: 6,12 weeks
Change in FPG (fasting plasma glucose) compared with baseline.
Measured: 6,12 weeks
Change in FINS (fasting serum insulin) compared with baseline.
Measured: 6,12 weeks
Change in 2h-PPG (Postprandial plasma glucose) compared with baseline.
Measured: 6,12 weeks
Change in the level of 2-hour postprandial C-peptide compared with baseline.
Measured: 6,12 weeks
Change in the level of 2-hour postprandial serum insulin compared with baseline.
Measured: 6,12 weeks
Change in BMI compared with baseline.
Measured: 6,12 weeks
Change in waist circumference compared with baseline.
Measured: 6,12 weeks
Change in hip circumference compared with baseline.
Measured: 6,12 weeks
Change in waist hip ratio compared with baseline.
Measured: 6,12 weeks
Change in body fat rate compared with baseline.
Measured: 6,12 weeks
Change in visceral fat area compared with baseline.
Measured: 6,12 weeks
Change in basal metabolic rate compared with baseline.
Measured: 6,12 weeks
Change in TC、TG、HDL and LDL compared with baseline.
Measured: 6,12 weeks
Change in Blood pressure parameter (SBP, DBP) compared with baseline.
Measured: 6,12 weeks
Change in inflammatory markers (hS-CRP, IL-6) compared with baseline.
Measured: 6,12 weeks
Change in gut microbiota composition compared with baseline.
Measured: 12 weeks
Change in serum metabolic profile compared with baseline.
Measured: 12 weeks
Safety of FMT
Rate of adverse events(reflux, aspiration, nausea, vomiting belching, abdominal distension, abdominal pain, diarrhea, constipation, infection, fever etc.).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongguan People's Hospital, Shenzhen Hengsheng Hospital, Shaoguan Qide Hospital, Shaoguan First People's Hospital, First People's Hospital of Zhaoqing, Suixi Hospital of Guangdong Medical University, Shantou Central Hospital, People's Hospital of Xinxing County, Shantou Longhu People's Hospital
- Responsible party
- Sponsor
- Investigators
- Hong Chen, MD, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253768
- Sponsor's protocol ID
- SETOM
- Acronym
- SETOM
- Status last verified
- Mar 2024
- First submitted
- 23 Dec 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Human Microbiota Transplantation for Overweight and Obese Type 2 Diabetes Mellitus ( SETOM ): A Randomized, Double-blind, Placebo-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05253768
- Acronym / sponsor ID
- SETOM / SETOM
- Conditions
- Type 2 Diabetes Mellitus, Overweight and Obesity
- Keywords
- Fecal Microbiota Transplantation(FMT), Type 2 Diabetes Mellitus, obesity, Weight Loss, Diabetes Mellitus, Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Dongguan People's Hospital, Shenzhen Hengsheng Hospital, Shaoguan Qide Hospital, Shaoguan First People's Hospital, First People's Hospital of Zhaoqing, Suixi Hospital of Guangdong Medical University, Shantou Central Hospital, People's Hospital of Xinxing County, Shantou Longhu People's Hospital
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Feb 2022 (actual)
- 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 main purpose is to evaluate whether the percentage of body weight change from baseline to week 12 is higher than that in the placebo group.
In this randomized, double-blind, placebo-controlled study, 39 patients fulfilling the study criteria will be enrolled in the study. Patients will be randomized(2:1) to either FMT or placebo.
Detailed description
This is a randomized, double-blind, placebo-controlled study evaluating fecal microbiota transplantation from lean healthy donors to reduce the patients' weight. Patients wishing to participate will be evaluated whether they qualify for the study regarding the aforementioned inclusion and exclusion criteria. The details of the experiment and potential risks or discomforts involved in it will be presented, after which the patients will sign informed consent forms.
In this study, patients will be randomly assigned to the experimental group and the control group in a 2:1 ratio according to a random allocation table. The table will be formulated on the basis of the random numbers generated by SPSS.
The study will comprise of three parts:
- Baseline - two weeks of run-in and screening period.
- Ensure that each patient reads and signs informed consent.
- Collect demographic data.
- Ask about past medical history, current medical history, surgical history, allergy history, etc.
- Ask about previous medication and combination medication.
- Complete the FFQ questionnaire.
- Collect information about vital signs, physical examination, BMI, ECG, conventional index and therapeutic effect index.
- Collect 2 tubes of stool samples for fecal metagenomics sequencing and three tubes of blood samples for measuring serum metabolomics and inflammatory index (IL-6).
- Review whether patients qualify for participate in the study according to the inclusion and exclusion criteria.
- Dietitian will give diet, exercise lifestyle intervention guidance to patients.
- FMT/ placebo intervention-patients will receive three interventions every two weeks. Four donors of any gender will be recruited for this study. Patients will receive 200ml FMT from donors with the same gender or receive the same amount of placebo FMT. FMT will be packaged in a 50ml sterile syringe or in an enema bag/surgical nutrition bag, the outer package of which will be affixed with the unique identifiable bar code label generated according to the biological specimen bank of the Department of Laboratory Medicine. The placebo FMT will be mainly composed of normal saline and glycerin and will be packaged in the same way as FMT. The night before receiving FMT or placebo FMT via nasointestinal tube, patients will go through proton pump inhibitors(oral 20mg esomeprazole or 40mg omeprazole). The end of the nasointestinal tube should reach at least the patient's duodenum, or reach the patient's jejunum if the patient cooperate. To prevent aspiration, the patient's upper body must maintain an upright posture of 45 degrees for 4 hours after the infusion. Before the first intervention, information about drug combination, vital signs, physical examination, BMI, body composition analysis and adverse events of patients will be collected, and advice of diet and lifestyle will be given to patients. Before the second intervention and before the third intervention, information about drug combination, vital signs, physical examination, BMI, renal function, liver function, blood fat, fasting blood glucose/C-peptide/insulin, body composition analysis and adverse events of patients will be collected, and advice of diet and lifestyle will be given to patients.
- Follow-up meetings - total follow up of 6 weeks after FMT/placebo intervention. Meetings will occur 2 weeks and 6 weeks after the third intervention.
During every follow-up meeting, information about drug combination, vital signs, physical examination, BMI, inflammatory biomarkers, renal function, liver function, blood fat, HbAlc, fasting blood glucose/C-peptide/insulin, 2-hour postprandial blood glucose/C-peptide/insulin, body composition analysis and adverse events of patients will be collected, and advice of diet and lifestyle will be given to patients. In the second follow-up meeting, there will be a fecal metagenomics sequencing and a serum metabonomics analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Biological: Fecal microbiota transplant (FMT)Patients who receive a fecal microbiota transplantation via a nasointestinal tube. |
| placebo | Placebo comparator | Other: normal saline and glycerin/food coloringPatients who receive a placebo FMT via a nasointestinal tube. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A diagnosis of T2DM (≥2 months) according to the dagnostic and typing criteria of Chinese guideline for type 2 diabetes
- Control the blood glucose level through diet or exercise only and never receive any hypoglycemic agent in the last 8 weeks.
- Continuous treatment with insulin and its analogues for no more than 14 days in the last year. (The duration of treatment with insulin and its analogues for gestational diabetes mellitus is not included)
- 7.0%≤HbA1c≤10.0%
- Fasting plasma glucose(FPG)<15mmol/L
Key exclusion criteria (35 listed)
- 1. Diagnosed with T1D, gestational diabetes mellitus(GDM) or other special type of diabetes.
- 2. The presence of any of the following medical histories or clinical conditions that the investigator believes the risks of participation in the study outweigh the benefits or the treatment of combined conditions that may affect subject compliance or the objectivity of the study outcomes.
- Patients with gastrointestinal disease(such as Irritable bowel syndrome, inflammatory bowel disease, peptic ulcer, gastrointestinal bleeding history, etc.) or history of gastrointestinal surgery(such as gastrectomy, gastroenterostomy, bowel resection, etc.) and are assessed to be unsuitable to participate in this clinical trial by researchers.
- Patients with severe diabetic complications (diabetic ketoacidosis, hyperglycemic hyperosmolar condition etc.) in the last 6 months.
- Patients in unstable condition and need therapy for proliferative diabetic retinopathy or maculopathy, severe diabetic neuropathy, diabetic foot or intermittent claudication in the last 6 months.
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 |
|---|---|---|
| Fecal microbiota transplant (FMT)Patients will randomized to a fecal microbiota transplantation by using a nasointestinal tube for 3 times in 4 weeks(0,2,4) without undergoing an enema before the treatment. The amount of FMT is 200ml at one time. Patients are given the same lifestyle guidance and nutritional advice. | Biological | intervention |
| normal saline and glycerin/food coloringPatients will receive an equivalent volume of normal saline and glycerin/food coloring via a nasointestinal tube (sham transplantation) for 3 times in 4 weeks(0,2,4) without undergoing an enema before the treatment. The amount of placebo FMT is 200ml at one time. Patients are given the same lifestyle guidance and nutritional advice. | Other | placebo |
Primary outcome
Percentage of change in weight compared with baseline.
Time frame: 12 weeks
26 secondary outcomes
The absolute value of change in weight compared with baseline.
Time frame: 6,12 weeks
Proportion of at least 5% reduction in weight.
Time frame: 12 weeks
Proportion of at least 10% reduction in weight.
Time frame: 12 weeks
Proportion of at least 15% reduction in weight.
Time frame: 12 weeks
Proportion of patients with HbA1c < 7.0%.
Time frame: 12 weeks
Proportion of patients with HbA1c < 6.5%.
Time frame: 12 weeks
Change in the level of HbA1c.
Time frame: 6,12 weeks
Change in FCP (fasting C-peptide) compared with baseline.
Time frame: 6,12 weeks
Change in FPG (fasting plasma glucose) compared with baseline.
Time frame: 6,12 weeks
Change in FINS (fasting serum insulin) compared with baseline.
Time frame: 6,12 weeks
Change in 2h-PPG (Postprandial plasma glucose) compared with baseline.
Time frame: 6,12 weeks
Change in the level of 2-hour postprandial C-peptide compared with baseline.
Time frame: 6,12 weeks
Change in the level of 2-hour postprandial serum insulin compared with baseline.
Time frame: 6,12 weeks
Change in BMI compared with baseline.
Time frame: 6,12 weeks
Change in waist circumference compared with baseline.
Time frame: 6,12 weeks
Change in hip circumference compared with baseline.
Time frame: 6,12 weeks
Change in waist hip ratio compared with baseline.
Time frame: 6,12 weeks
Change in body fat rate compared with baseline.
Time frame: 6,12 weeks
Change in visceral fat area compared with baseline.
Time frame: 6,12 weeks
Change in basal metabolic rate compared with baseline.
Time frame: 6,12 weeks
Change in TC、TG、HDL and LDL compared with baseline.
Time frame: 6,12 weeks
Change in Blood pressure parameter (SBP, DBP) compared with baseline.
Time frame: 6,12 weeks
Change in inflammatory markers (hS-CRP, IL-6) compared with baseline.
Time frame: 6,12 weeks
Change in gut microbiota composition compared with baseline.
Time frame: 12 weeks
Change in serum metabolic profile compared with baseline.
Time frame: 12 weeks
Safety of FMT
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
Hong Chen, MD principal investigator
Zhujiang Hospital
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 Fecal microbiota transplant (FMT) and normal saline and glycerin/food coloring in people with Type 2 Diabetes Mellitus and Overweight and Obesity, run by Zhujiang Hospital at 1 site in China.
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 8 inclusion and 35 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 15 Mar 2024. 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 China. 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 Hong Chen, MD (13602759769, rubychq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of change in weight compared with baseline. (time frame: 12 weeks). 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 15 Mar 2024.