Type 1 Diabetes
Conditions
Keywords
washed microbiota transplantation, type 1 diabetes mellitus, glycemic variability, daily insulin dosage, hypoglycemia, insulin sensitivity
Brief summary
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
OTHERWMT
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.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to enter the study: 1. At the time of informed consent, male or non-pregnant or non-lactating female. 2. The diagnostic criteria for T1DM are confirmed by previous medical record. 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean daily insulin dosage of participants | One-week, Two-week, Four-week post-WMT | The mean daily insulin dosage of participants in past week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The SD of blood glucose (SDBG, mmol/L) of type 1 diabetes mellitus. | One-week, Two-week, Four-week post-WMT | The standard deviation of measured values during immediate blood glucose monitoring |
| The largest amplitude of glycemic excursions (LAGE, mmol/L) of type 1 diabetes mellitus. | One-week, Two-week, Four-week post-WMT | The range of blood glucose values observed during immediate blood glucose monitoring |
| The mean amplitude of glycemic excursion (MAGE, mmol/L) of type 1 diabetes mellitus. | One-week, Two-week, Four-week post-WMT | After filtering out blood glucose fluctuations below a certain threshold (usually 1 SD), the average fluctuation amplitude is calculated based on the direction of the first significant fluctuation |
| The mean of daily differences (MODD, mmol/L) of type 1 diabetes mellitus. | One-week, Two-week, Four-week post-WMT | The average absolute difference between corresponding measured values over a continuous 48-hour period |
| The postprandial glucose excursions (PPGE, mmol/L) of type 1 diabetes mellitus. | One-week, Two-week, Four-week post-WMT | The average absolute difference between post-meal blood glucose taken 2 hours after three meals and the corresponding pre-meal blood glucose. |
| The Blood glucose of Time in Range (TIR, percent) of type 1 diabetes mellitus. | One-week, Two-week, Four-week post-WMT | The proportion of time spent within the target blood sugar range (typically 3.9 to 10.0mmol/L) over a 24-hour period |
| The coefficient of variation (CV, percent) of type 1 diabetes mellitus. | One-week, Two-week, Four-week post-WMT | CV=(SDBG÷MBG)×100% |
| The frequency of hypoglycemia or duration of hypoglycemic state in the last 1 week | One-week, Two-week, Four-week post-WMT | Hypoglycemia is defined as blood glucose \< 3.9 mmol/L |
| The islet β-cell function after WMT compared with baseline | Three-day, One-week, Two-week, Four-week post-WMT | 2-hour postprandial C-peptide release was used to reflect islet β-cell function |
| The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 | One-week, Two-week, Four-week post-WMT | The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.) |
| The mean blood glucose (MBG, mmol/L) of type 1 diabetes mellitus. | One-week, Two-week, Four-week post-WMT | Average values obtained from immediate blood glucose monitoring |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Backup ContactBota Cui
Outcome results
None listed