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 @ 3:14 AM
Ignite Modification Date:
2025-12-25 @ 3:14 AM
NCT ID:
NCT00285805
Eligibility Criteria:
Inclusion Criteria:
* Healthy but with 2 features of the metabolic syndrome (AHA/NHLBI) (16)
* Willing and able to provide a signed and dated written informed consent.
* Male or female subject aged between 30 and 70 years
Exclusion Criteria:
* Fasting glucose \> 7,0 mmol/L or the use of hypoglycaemic agents. If fasting plasma glucose is between 6.1 and 7,0 mmol/L,an oral 75 g glucose test will be performed to exclude diabetes mellitus.
* Exposure to a PPAR-g agonist during the last 4 months or a documented significant hypersensitivity to a PPAR-g agonist.
* Participant in another study.
* Angina or heart failure (NYHA I-IV).
* Clinically significant liver disease (3 times the upper normal limit of ALAT, ASAT, AF, γGT or LDH)
* Clinically significant anaemia (male Hb \< 6,9 mmol/L, female \< 6,25 mmol/L)
* Creatinin clearance \< 40 mL/min
* Pregnancy, lactation
* Alcohol or drug abuse. Liquorice
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT00285805
Study Brief:
Protocol Section:
NCT00285805