Safety and Efficacy of Human Microbiota Transplantation for Overweight and Obese Type 2 Diabetes Mellitus

NCT05253768 | Recruiting Phase 2

• 1 other identifier: SETOM
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. Patients will be randomized(2:1) to either FMT or placebo.

Conditions

Type 2 Diabetes Mellitus; Overweight and Obesity

Keywords

Fecal Microbiota Transplantation(FMT); Type 2 Diabetes Mellitus; obesity; Weight Loss; Diabetes Mellitus; Overweight

Outcome Measures

Primary Outcomes (1)

• Percentage of change in weight compared with baseline.

  12 weeks

Secondary Outcomes (26)

• The absolute value of change in weight compared with baseline.

  6,12 weeks

• Proportion of at least 5% reduction in weight.

  12 weeks

• Proportion of at least 10% reduction in weight.

  12 weeks

• Proportion of at least 15% reduction in weight.

  12 weeks

• Proportion of patients with HbA1c < 7.0%.

  12 weeks

Study Arms (2)

intervention

EXPERIMENTAL

Patients who receive a fecal microbiota transplantation via a nasointestinal tube.

Biological: Fecal microbiota transplant (FMT)

placebo

PLACEBO COMPARATOR

Patients who receive a placebo FMT via a nasointestinal tube.

Other: normal saline and glycerin/food coloring

Interventions

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.

intervention

normal saline and glycerin/food coloring OTHER

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.

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• %≤HbA1c≤10.0%
• Fasting plasma glucose(FPG)\<15mmol/L
• kg/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.

You may not qualify if:

• \. Diagnosed with T1D, gestational diabetes mellitus(GDM) or other special type of diabetes.
• \. 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.
• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Dongguan People's Hospital: collaborator
• Shenzhen Hengsheng Hospital: collaborator
• Shaoguan Qide Hospital: collaborator
• Shaoguan First People's Hospital: collaborator
• Zhaoqing First People's Hospital: collaborator
• Suixi Hospital of Guangdong Medical University: collaborator
• Shantou Central Hospital: collaborator
• People's Hospital of Xinxing County: collaborator
• Shantou Longhu People's Hospital: collaborator

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity; Weight Loss; Diabetes Mellitus

Interventions

Fecal Microbiota Transplantation; Saline Solution

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hong Chen, MD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Chen, MD

CONTACT

13602759769; rubychq@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 24, 2022
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CN (1)