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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT03449251
Eligibility Criteria:
Inclusion Criteria:
Healthy participants
* Have given written informed consent to participate
* Aged 18 to 70 years inclusive
* Male or female
* Current non-smoker
* If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
* BMI in range for studies 1 and 4: 18.5-24.9 kg/m2 with waist circumference lower than 88 centimetres (35 inches) for women or 102 cm (40 inches) for men, and/or body fat level less than 32 % for women or 25% for men
* BMI in range for studies 2 and 3: 18.5-30.0 kg/m2 without limitations in waist circumference or body fat level
Overweight/obese participants
* Have given written informed consent to participate
* Aged 18 to 70 years inclusive
* Male or female
* Current non-smoker
* If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
* BMI in range of 25-34.9 kg/m2 (inclusive) with either waist circumference higher than 88cm (35 inches) for women or 102 cm (40 inches) for men, and/or body fat levels in excess of 32% for women or 25% for men
Participants with type 2 diabetes mellitus
* Have given written informed consent to participate
* Aged 18 to 70 years inclusive
* Male or female
* Current non-smoker
* If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
* BMI in range of 25-34.9 kg/m2 (inclusive) with either waist circumference higher than 88cm (35 inches) for women or 102 cm (40 inches) for men, and/or body fat levels in excess of 32% for women or 25% for men
* Documented diagnosis of Type 2 Diabetes Mellitus, either diet controlled or treated with oral hypoglycaemic therapy
Exclusion Criteria:
* Hypersensitivity to any of the study drugs or excipients
* Systemic Hypertension (sustained BP \>160/100mmHg) or hypotension (systolic BP below 90 mmHg)
* Known heart disease
* Implanted heart pace-maker or implantable cardioverter defibrillator (ICD)
* Known active malignancy
* Known renal failure (creatinine \>140µmol/L)
* Known neurological disease
* History of Scleroderma (Study 4 only)
* Current pregnancy, breast feeding
* Use of vasoactive medications or NSAIDS/aspirin within 24 hours of study visits
* Use of caffeine within 24 hours of study visits
* Current involvement in the active treatment phase of other research studies, (excluding observations/non-interventional)
* Second or third-degree AV block, sino-atrial block, sick sinus syndrome or sinus bradycardia
* Known HIV, hepatitis B or C
* Needle phobia
* Participants treated with formal anticoagulant therapy such as, but not limited to, heparin, warfarin or clopidogrel
* Diagnosis of Type 1 Diabetes Mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP1 agonists
* BMI \<18.5
* Aged \<18 or \>70 years
* Any other clinical reason which may preclude entry in the opinion of the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03449251
Study Brief:
Protocol Section:
NCT03449251