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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT01285232
Eligibility Criteria:
Inclusion Criteria:
* Impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/L) and/or HbA1c levels of 5.7-6.4%
* BMI \>25 kg/m2
* Age 40-70 years
Exclusion Criteria:
* Known diabetes mellitus
* Fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
* Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)
* Use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
* Signs of current infection (fever, C-reactive protein \>30 mmol/L, treatment with antibiotics, previous or current diagnosis of tuberculosis)
* A history of recurrent infections
* Pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)
* Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
* Renal disease defined as MDRD \< 60 ml/min/1.73m2
* Neutropenia \< 2x 109/L
* Inability to understand the nature and extent of the trial and the procedures required.
* Any medical condition that might interfere with the current study protocol
* Participation in a drug trial within 60 days prior to the first dose
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01285232
Study Brief:
Protocol Section:
NCT01285232