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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT06555393
Eligibility Criteria:
Inclusion Criteria:
Healthy control group:
* Men and women aged between 18 and 70 years living in Edmonton (or Edmonton area/driving distance).
* Normal weight (BMI below 25 kg/m2 or Asian population below 23 kg/m2 )
* Waist circumference below the following ethnic specific cut offs: Canada / USA: \<102 cm men and \<88 cm women; Europids, Middle-Eastern, Sub-Saharan African, and Mediterranean: \<94 cm men and \<80 cm women; Asians, Japanese, South and Central Americans: \<90 cm men and \<80 cm women
* Fasting glucose \<5.6 mmol/L
* HbA1c \<5.6 %
* Blood pressure \<130/85 mmHg
* Triglycerides \<1.7 mmol/L
* HDL-Cholesterol \>1.03 mmol/L men and \>1.29 mmol/L women
* Body weight stable (within 3% fluctuation) for at least 6 months prior to the study
* Individuals who have never smoke, have smoke less than 100 cigarettes in their life or who are long term quitter (quit smoking a year or more ago)
Individuals at risk of diabetes/having type 2 diabetes:
* Men and women aged between 18 and 70 years living in Edmonton (or Edmonton area/driving distance).
* Overweight or obesity (BMI above 25 kg/m2 or Asian population above 23 kg/m2)
* Waist circumference at or above the following ethnic specific cut offs: Canada / USA: ≥ 102 cm men and ≥ 88 cm women; Europids, Middle-Eastern, Sub-Saharan African, and Mediterranean: ≥ 94 cm men and ≥ 80 cm women; Asians, Japanese, South and Central Americans: ≥ 90 cm men and ≥ 80 cm women
* Fasting glucose ≥ 6.0 mmol/L
* HbA1c ≥ 6.0 %
* Body weight stable (within 3% fluctuation) for at least 6 months prior to the study
* Individuals who have never smoke, have smoke less than 100 cigarettes in their life or who are long term quitter (quit smoking a year or more ago)
Exclusion Criteria:
* Individuals with a previous history of CVD, renal disorder, monogenic dyslipidemia, with endocrine disorders other than T2D
* Individuals taking chronic anti-inflammatory drugs (including aspirin, antihistamines, and omega-3 supplements)
* Pregnant/lactating women
* Individuals aged above 70 years
* Smokers (current smokers: daily/occasional and those who have smoked more than 100 cigarettes in their life)
* Individuals with specific nutritional restrictions (e.g. vegetarianism excluding eggs from their diet, vegan or with egg allergy) will be excluded
* Individuals with poorly controlled (HbA1c \>12.0%) diabetes or taking exogenous insulin will be excluded. Other anti-diabetic and lipid-lowering medications will be documented.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06555393
Study Brief:
Protocol Section:
NCT06555393