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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02472951
Eligibility Criteria:
Inclusion Criteria:
* Men age 18-70 years
* Postmenopausal women age 55-70 years
* Non-smoker (abstinent at least 6 months)
* HbA1c \< 74 mmol/mol
* Fasting blood glucose \< 11 mmol/L (mean of 3 measurements)
* Negative (\<25 IU/L) plasma glutamate decarboxylase (GAD-65) antibodies (IgG)
* Hemoglobin \> 7.5 mmol/L (men); \> 6.8 mmol/L (women)
* Normal thrombocytes (140-400 x 109/L)
* eGFR \> 45 ml/min per 1.73 m2
* Alkaline phosphatase \< 140 IU/L
* Alanine aminotransferase \< 70 IU/L
* Normal International Normalized Ratio (0.9-1.2)
Exclusion Criteria:
* Critical illness
* Anti-diabetic drugs other than metformin (maximum of 2000 mg / day)
* Steroid treatment e.g. prednisolone
* Reported or journalized severe food allergy or intolerance
* Reported or journalized gut disease e.g. Crohn's disease, Coeliac disease
* Reported or journalized alcohol dependence syndrome
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02472951
Study Brief:
Protocol Section:
NCT02472951