Diabetes
Conditions
Brief summary
This is a single-center, phase IIT clinical trial to evaluate autologous regenerative islet transplantation for insulin-dependent diabetes mellitus. Twenty patients with insulin-dependent diabetes mellitus will be enrolled: poor blood glucose control despite intensive exogenous insulin therapy. The primary endpoint will be defined by the return to normal blood glucose control without insulin at 12 months after transplantation.
Interventions
PROCEDUREAutologous regenerative islet transplantation for insulin-dependent diabetes mellitus
Islet transplantation was completed using percutaneous transhepatic portal vein puncture. After transplantation, rabbit anti human thymocyte immunoglobulin (ATG) or basiliximab was used as induction therapy and low-dose tacrolimus combined with sirolimus or mycophenolate mofetil were used as immunosuppressive maintenance therapy.
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Insulin-dependent diabetes mellitus, the specific criteria are (1 of 4-6 is sufficient). 1. Age: 18-70 years old; 2. History of diabetes mellitus \>1 year; 3. Insulin-dependent and total daily insulin dose \>20 units; 4. Poor blood glucose control despite intensive exogenous insulin therapy (or high blood glucose fluctuation, glycation \>8% ); 5. Frequent hypoglycemic episodes with unconsciousness; 6) Diabetic nephropathy, patients who need to receive kidney transplantation.
Exclusion criteria
* 1\) Severe heart disease; 2) Severe mental disorders, poor compliance or alcohol abuse; 3) Active infection or with malignancy; 4) Weight greater than 25% of ideal weight; 5) Evidence of endogenous insulin secretion, such as type 2 diabetes; 6) Smoking; 7) During gestation or preparation for gestation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in C-peptide | before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total | Changes in C-peptide (fasting C-peptide and post-stimulated C-peptide) of patients during the study period since baseline. |
| Changes in insulin | before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total | Changes in insulin (fasting insulin and post-stimulated insulin) of patients during the study period since baseline. |
| Changes in HbA1c values | before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total | Changes in HbA1c values of patients during the study period since baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the patient's daily insulin unit requirement | Data will be recorded every day after the surgery until insulin treatment stops during the follow-up time of 12 months. | Change in the patient's daily insulin unit requirement during the study period. |
| Number of severe hypoglycemic events | Data will be recorded every week after the surgery during the follow-up time of 12 months. | Number of severe hypoglycemic events in patients during the study period. |
| Changes in glucagon | before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total | Changes in glucagon since baseline during the study period. |
Countries
China
Contacts
Primary ContactHao Yin
Outcome results
None listed