Phase
Condition
Diabetes Prevention
Diabetes And Hypertension
Diabetes Mellitus, Type 1
Treatment
N/AClinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with type 1 diabetes
18 <Age <55 years
Plasma C-peptide <0.2 ng/ml basal and stimulated glucagon
Evolution of diabetes for more than 5 years
Regular patient follow-up (> or equal to 2 visits per year from the samediabetologist)
Patient who received the information and have given their consent in writing
Absence of HIV, hepatitis B and hepatitis C, HTLV-1-2
ABO compatibility with the donor
Cross match negative
Anti-HLA antibodies (class I and / or class II) detected by lymphocytotoxicity <20%
PCR negative for the BK virus in the blood (so as not to amplify the BK virusreplication with the ATG).
Accepting patients effective contraception during the study period For patients in group IA
Glomerular filtration rate estimated by the MDRD> 50 ml/min/1.73m2
No perception of hypoglycaemia (less than 0.54 mg/dl glucose) at least one valuedocumented in the two years preceding and/or
Occurrence of at least one severe hypoglycemic episode (with a third required) andunexplained in the two years before and/or at least two episodes of ketoacidosis peryear
Average HbA1c> 8.5% over two years, despite intensified treatment (basal pattern,bolus)
• For patients in the IAK
functional renal graft for at least 1 year
glomerular filtration rate> 50 ml/min/1.73 m2
proteinuria <0.5 g/day
Absence of acute rejection in renal previous 6 months
Exclusion
Exclusion Criteria:
BMI > 28
Need insulin > 1 U/kg per day
Pregnancy, lactation
Intention of childbearing for the two sexes
Psychiatric Disorders
Inability to communicate or cooperate with the investigator
Lack of therapeutic compliance, including HbA1C > 12%
Chronic liver disease
Progressive heart disease myocardial infarction within 6 months prior to inclusion,unbalanced CHD)
Proliferative retinopathy unstabilized
History of cancer, whatever the date, except for basal or squamous cell skin cancersover 1 year.
Systemic infection
Chronic high risk of requiring corticosteroids
Need for long-term corticosteroid, outside that specified in renal transplantation,the patients will be weaned before transplantation
Anticoagulant vitamin K or antiplatelet treatments
Disorders of hemostasis TP <60 % TCA > 1.5 times the control
Anti-HLA antibodies ( class I and/or class II ) detected by lymphocytotoxicity > 20%
Platelets < 100 giga/L and/or neutrophils <1.5 giga/L
Chronic intoxication by alcohol, tobacco, or other substance (abstinence > 6 monthsrequired)
Active infection by hepatitis B, hepatitis C and HIV, HTLV-1-HTLV2
Ascites
Study Design
Connect with a study center
Saint Louis hospital
Paris, Ile de France 75010
FranceActive - Recruiting

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