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:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00303394
Eligibility Criteria:
Inclusion Criteria:
* Age \>20
* Diabetes mellitus Type 2 (American Diabetes Association criteria) of at least 3 months duration
* HbA1c \>7.5%
* Body-mass index (BMI) \> 27
Exclusion Criteria:
* Positive GAD 65 or IA-2 antibodies at inclusion.
* HbA1c \>12%, polyuria and thirst (exclusion of severely decompensated patients)
* C-peptide \< 400pmol/l (basal )
* Established anti-inflammatory therapy (includiung cortisone, NSAID, Cox-2-inhibitor). Low dose aspirin (£ 100mg) will be tolerated.
* CRP \>30 mg/dl, fever, current treatment with antibiotics, or chronic granulomatous infections (e.g. tuberculosis) in the history or on a screening chest X-ray.
* Neutropenia or anemia (leucocyte count \< 2.0x109 /l, hemoglobin \<11g/dl for ma les or \<10g/dl for females)
* Pregnancy or breast-feeding. When appropriate (fertile women),anticonception for at last 3 month prior inclusion will be required.
* Severe liver or renal disease ( AST or ALT\>3 times the upper limit of normal laboratory range, serum creatinine \>130mM)
* Ongoing malignant neoplasm
* Use of any investigational drug within 30 days of enrollment into the study or within 5 half-lives of the investigational drug (whichever is longer)
* Immunosuppressive treatment or immunodeficient diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00303394
Study Brief:
Protocol Section:
NCT00303394