type 2 diabetes mellitus
Conditions
Interventions
experimental group:islet after kidney transportation
control group:kidney transportation
Sponsors
Tianjin First Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 to 65 years; 2. Ability to provide written informed consent; 3. Mentally stable and able to comply with the procedures of the study protocol; 4. Clinical history compatible with T1D with onset of disease at < 40 years of age, insulin-dependence for = 5 years at the time of enrollment; 5. Patients will not be able to carry out follow-up islet transplantation for at least 3 months after kidney transplantation. Upon the completion of kidney transplantation, patients should take the immunosuppressive drugs regularly. The amount of glucocorticoid should be no more than 10 mg per day; 6. After receiving the kidney transplantation, the renal function should be stable with no rejection and severe infection for 3 consecutive months; 7. At least one episode of severe hypoglycemia within the last 12 months, OR reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more during the screening period or within the last 6 months.
Exclusion criteria
Exclusion criteria: 1. Previous transplantation failure, except for the failure in the combined pancreas and renal transplantation due to thrombosis or surgical anastomosis failure; 2. Untreated proliferative diabetic retinopathy; 3. Blood Pressure: SBP >160 mmHg or DBP >100 mmHg; 4. GFR 300mg/g creatinine); 6. PRA>50% OR PRA1.5 times normal upper limits will exclude a patient;l 18. Symptomatic cholecystolithiasis (Except for the transplantation sites other than portal vein); 19. Acute or chronic pancreatitis; 20. Symptomatic peptic ulcer disease; 21. Severe unremitting diarrhea, vomiting or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications; 22. Hyperlipidemia despite; medical therapy (fasting low-density lipoprotein [LDL] cholesterol >130 mg/dL, treated or untreated; and/or fasting triglycerides >200 mg/dL); 23. Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for the use of = 5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only; 24. Administration of live attenuated vaccine(s) within 2 months of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;creatinine;urine protein; | — |
Countries
China
Contacts
Public ContactShen Zhongyang
Tianjin First Center Hospital
Outcome results
None listed