Washed Microbiota Transplantation for Type 1 Diabetes Mellitus

Official title

Washed Microbiota Transplantation for Type 1 Diabetes Mellitus: a Real World Research

Overview

This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation (WMT) for patients with Type 1 Diabetes Mellitus (T1DM).

Detailed description

At least 20 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, blood glucose fluctuation and variability, daily insulin dosage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.

Interventions

• Other WMT
  Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive three doses of WMT for T1DM.

Primary outcome measures

• The mean daily insulin dosage of participants [Time frame: One-week, Two-week, Four-week post-WMT]

Secondary outcome measures (11)

• The Blood glucose of Time in Range (TIR, percent) of type 1 diabetes mellitus. [Time frame: One-week, Two-week, Four-week post-WMT]
• The SD of blood glucose (SDBG, mmol/L) of type 1 diabetes mellitus. [Time frame: One-week, Two-week, Four-week post-WMT]
• The largest amplitude of glycemic excursions (LAGE, mmol/L) of type 1 diabetes mellitus. [Time frame: One-week, Two-week, Four-week post-WMT]
• The mean amplitude of glycemic excursion (MAGE, mmol/L) of type 1 diabetes mellitus. [Time frame: One-week, Two-week, Four-week post-WMT]
• The mean of daily differences (MODD, mmol/L) of type 1 diabetes mellitus. [Time frame: One-week, Two-week, Four-week post-WMT]
• The postprandial glucose excursions (PPGE, mmol/L) of type 1 diabetes mellitus. [Time frame: One-week, Two-week, Four-week post-WMT]
• The mean blood glucose (MBG, mmol/L) of type 1 diabetes mellitus. [Time frame: One-week, Two-week, Four-week post-WMT]
• The coefficient of variation (CV, percent) of type 1 diabetes mellitus. [Time frame: One-week, Two-week, Four-week post-WMT]
• The frequency of hypoglycemia or duration of hypoglycemic state in the last 1 week [Time frame: One-week, Two-week, Four-week post-WMT]
• The islet β-cell function after WMT compared with baseline [Time frame: Three-day, One-week, Two-week, Four-week post-WMT]
• The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 [Time frame: One-week, Two-week, Four-week post-WMT]

Eligibility criteria

Inclusion criteria

Subjects must meet all of the following inclusion criteria to enter the study:

• At the time of informed consent, male or non-pregnant or non-lactating female.
• The diagnostic criteria for T1DM are confirmed by previous medical record.
• The subject or his/her legal representative gives informed consent, fully nderstands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.

Exclusion criteria

Subjects meeting any of the following exclusion criteria must be excluded from the study:

• Diagnosed as any type of diabetes other than type 1 diabetes mellitus;
• Subjects with severe life-threatening complications diabetes (such as ketoacidosis, or acute coronary syndrome, etc.);
• At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
• According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical U — Nanjing

Publications

• Wang L, Peng W, Zhao Z, Zhang M, Shi Z, Song Z, Zhang X, Li C, Huang Z, Sun X, Wang L, Zhou M, Wu J, Wang Y. Prevalence and Treatment of Diabetes in China, 2013-2018. JAMA. 2021 Dec 28;326(24):2498-2506. doi: 10.1001/jama.2021.22208. PMID 34962526
• Li Y, Teng D, Shi X, Qin G, Qin Y, Quan H, Shi B, Sun H, Ba J, Chen B, Du J, He L, Lai X, Li Y, Chi H, Liao E, Liu C, Liu L, Tang X, Tong N, Wang G, Zhang JA, Wang Y, Xue Y, Yan L, Yang J, Yang L, Yao Y, Ye Z, Zhang Q, Zhang L, Zhu J, Zhu M, Ning G, Mu Y, Zhao J, Teng W, Shan Z. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: PMID 32345662
• Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)(Part 1). Chinese Journal of Practical Internal Medicine. 2020;41(8):668-695.
• Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)(Part 2). Chinese Journal of Practical Internal Medicine. 2020;41(9):757-784.
• Liu J, Liu M, Chai Z, Li C, Wang Y, Shen M, Zhuang G, Zhang L. Projected rapid growth in diabetes disease burden and economic burden in China: a spatio-temporal study from 2020 to 2030. Lancet Reg Health West Pac. 2023 Feb 3;33:100700. doi: 10.1016/j.lanwpc.2023.100700. eCollection 2023 Apr. PMID 36817869
• Zhong VW, Yu D, Zhao L, Yang Y, Li X, Li Y, Huang Y, Ding G, Wang H. Achievement of Guideline-Recommended Targets in Diabetes Care in China : A Nationwide Cross-Sectional Study. Ann Intern Med. 2023 Aug;176(8):1037-1046. doi: 10.7326/M23-0442. Epub 2023 Aug 1. PMID 37523704
• Experts consensus on management of glycemic variability of diabetes mellitus. Chin J Endocrinol Metab. 2017;33(8):633-636.
• Coutinho M, Gerstein HC, Wang Y, Yusuf S. The relationship between glucose and incident cardiovascular events. A metaregression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. Diabetes Care. 1999 Feb;22(2):233-40. doi: 10.2337/diacare.22.2.233. PMID 10333939

Identifiers

NCT: NCT06256614 · WMT-RWS-T1DM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗