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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT00325559
Eligibility Criteria:
Inclusion Criteria:
* Male
* Aged from 20 to 40 years
* Patients with type 1 diabetes mellitus lasting for at least 5 years (C-Peptide ≤ 0.3 nmol/l in the presence of a plasma glucose level ≥ 7 mmol/L, indicating insulin dependence)
* Insulin delivery by CSII (continuous subcutaneous insulin infusion) for at least 6 months
* Acceptable to good metabolic control, reflected by an HbA1c 5-8%
* Normal insulin sensitivity, reflected by a daily insulin requirement of 0.3-1.0 U/kg body weight
* minimum 30' of moderate exercise 3 times per week
* BMI in the range of 18-25 kg/m2
Exclusion Criteria:
* Chronic complications of diabetes:
* Microalbuminuria (Mogensen nephropathy stadium ≥ III)
* Sensory neuropathy (vibration better than 5/8 at the metatarsophalangeal articulation of digitus I)
* Proliferating retinopathy
* No history of macro-vascular complications
* Clinically relevant autonomous neuropathy
* Smoking
* Abnormal thyroid function
* Major depression, psychosis and other severe personality disorders, claustrophobia
* Active neoplasia
* Contraindications to exposure to a 1.5 T magnetic field (pace-makers, osteosynthetic material, etc.)
* Abnormal liver or renal function (creatinine \> 130 µmol/L; ASAT and ALAT \> 3 times the upper reference limit)
* Excessive alcohol consumption (\>60g/d) or drug-abuse
* Refusal to give written informed consent
* Participation in another study
* Patients, who are not suitable for the study according to the study physician
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT00325559
Study Brief:
Protocol Section:
NCT00325559