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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00628056
Eligibility Criteria:
Inclusion Criteria:
* Diabetes Mellitus(WHO definition)
* HbA1C \<9
* No history of chest pain
* No evidence of Coronary Artery Disease or peripheral vascular disease
* Left ventricular ejection fraction over 50%
* No evidence of respiratory disease
Exclusion Criteria:
* Patients \< 16years or who cannot provide informed consent
* Evidence of significant epicardial coronary artery disease
* Evidence of peripheral vascular disease
* Abnormal liver function tests
* Clinically apparent peripheral neuropathy
* Severe chronic renal failure (creatinine \>250) or diabetic nephropathy
* Concomitant use of Amiodarone, Quinidine, Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme
* Patients on statin therapy for primary dyslipidemia.
* Patients with recurrent hypoglycaemia
* Women of child bearing age who are not using effective contraception (or if pregnancy test positive)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT00628056
Study Brief:
Protocol Section:
NCT00628056