Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT00321256
Eligibility Criteria:
Inclusion criteria:
* Type 1 diabetes mellitus
* Disease duration \> 5 years
* Despite intensive insulin therapy with tight endocrinologist supervision, persistence of the following conditions : hypoglycemia unawareness (\< 54 mg/dl) ; brittleness with at least two episodes of severe hypoglycemia ((defined by the need for assistance to correct the blood glucose level) or ketoacidosis per year , or often enough that the diabetologist judges the frequency to be life-threatening, the risk of transplantation and immunosuppression being judged to be less than the risk of the spontaneous course of uncontrolled diabetes
* Basal and stimulated plasma C-peptide \< 0.2 ng/ml
* Creatinine clearance ≥ 50 ml/min/1.73 m2 and proteinuria \< 0.5 g/24h
Exclusion criteria:
* Severe cardiovascular disease (recent myocardial infarction, unstable coronaropathy…)
* Severe systemic infection, including hepatitis C or B viral infection, HIV infection or tuberculosis
* Past or present neoplasia (with the exception of non melanoma skin cancers)
* Body weight \> 70 kg in women and BW \> 75 kg in men or BMI \> 26
* Stimulated C-peptide ≥ 0.3 ng/ml upon Glucagon or Arginine stimulation
* Age \< 18 years or \> 65 years
* Creatinine clearance \< 50 ml/min/1.73 m2
* Albuminuria \> 300 mg /24h or proteinuria \> 0.5 g/24h
* Hemoglobinemia \< 120 g/l in women or \< 130 g/l in men
* Liver disease (enzymes \> 1.5 N) such as cirrhosis or hepatitis
* Liver hemangioma
* Untreated proliferating diabetic retinopathy
* Pregnancy, lactation, pregnancy project or absence of efficient contraception
* Previous transplantation or immunization as judged by anti-HLA antibodies (\> 20%)
* Insulin needs \> 0.7 IU/kg/d or \> 50 IU
* HbA1c \> 12 %
* Any medical condition needing the chronic use of steroids
* Addison disease
* Any hemostasis disorder needing a prolonged treatment with anticoagulation drugs. Low-dose aspirin is permitted. coagulation disorders contraindicating the procedure, such as platelet count \< 100000/mm3.
* Serious life-threatening disease
* Medical or surgical history potentially influencing the absorption, distribution, metabolism and clearance of drugs
* Uncontrolled hypercholesterolemia (\> 350 mg/dl, 9.1 mmol/l) or hypertriglyceridemia (\> 500 mg/dl, 5.6 mmol/l)
* Leukocytes \< 4500/mm3, neutrophils \< 2000/mm3, platelets \< 100000/mm3
* Any medical or psychosocial condition susceptible to interfere with the study, such as drug abuse or recent alcohol abuse
* Poor therapeutic observance
* Failure to communicate or cooperate with the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00321256
Study Brief:
Protocol Section:
NCT00321256