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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT02459834
Eligibility Criteria:
Inclusion Criteria:
* Healthy participants:
* Adult males and non-pregnant females
* Normal weight
* Non-smokers
* Free of any disease or illness
* Do not regular take any medications
* Have a primary care physician
* Diabetes participants:
* Well-controlled diabetes on diet and/or oral antihyperglycemic agents
* Not taking insulin
* Free of any major illness
* Have a primary care physician
Exclusion Criteria:
* Healthy participants:
* Age \<18 or \>75y, Pregnant female
* Regular medication use
* Complementary or alternative medicine (CAM) use
* BMI\<18.5kg/m2, \>30kg/m2
* Prediabetes or diabetes (HbA1c≥6%, FBG≥6.1mmol/L)
* Hypertension (BP≥140/90), Dyslipidemia (Canadian Cardiovascular Society guidelines)
* Metabolic syndrome (harmonized definition)
* Polycystic ovarian syndrome
* Cardiovascular disease
* Gastrointestinal disease
* Previous bariatric surgery
* Liver disease (abnormal liver enzymes)
* Hyperthyroidism (abnormal TSH)
* Hypothyroidism (abnormal TSH)
* Nephropathy (albumin-to-creatinine ratio \[ACR\] \>20)
* Chronic kidney disease (eGFR \>60ml/min/1.73m2)
* Inflammatory conditions (CRP\>3g/L)
* Acute or chronic infection (abnormal white blood cell count (WBC), CRP\>3g/L)
* Anemia (abnormal Hb)
* Lung disease
* Cancer/malignancy
* Psychiatric illness
* Major surgery in the last 6 months
* Other major illness
* Smoker
* Heavy alcohol use (\>3 drinks/day)
* Diabetes participants:
* Age \<18 or \>75y
* Pregnant female
* Poorly controlled diabetes (HbA1c\>7.5%)
* Recent diabetes medication change (\< 3 months)
* Insulin use
* Complementary or alternative medicine (CAM) use
* BMI\<18.5kg/m2, ≥35kg/m2
* Cardiovascular disease
* Retinopathy
* Neuropathy
* Diabetic foot
* Gastrointestinal disease
* Previous bariatric surgery
* Liver disease (abnormal liver enzymes)
* Hyperthyroidism (abnormal TSH)
* Hypothyroidism (abnormal TSH)
* Anemia (abnormal Hb)
* Nephropathy (albumin-to-creatinine ratio \[ACR\] \>20)
* Chronic kidney disease (eGFR \>60ml/min/1.73m2)
* Inflammatory conditions (CRP\>3g/L)
* Acute or chronic infection (abnormal WBC, CRP\>3g/L)
* Lung disease
* Cancer/malignancy
* Psychiatric illness
* Major surgery in the last 6 months
* Other major illness
* Smoker
* Heavy alcohol use (\>3 drinks/day)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02459834
Study Brief:
Protocol Section:
NCT02459834