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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT01692002
Eligibility Criteria:
Inclusion Criteria:
Study 1: Healthy men and women aged between 18 and 70 years with BMI between 20-25 kg/m2 and with normal fasting blood glucose (below5.5mmol/l and HbA1C less than 5.7% will be eligible to volunteer.
Study 2: As for Study 1. Study 3: Cohort 1: Volunteers aged between 30 to 70 with a BMI between 25-35 kg/m2 who do not have impaired fasting glucose and have HbA1c below 5.7%.
Cohort 2: Volunteers aged between 30 to 70 years with a BMI between 25-35 kg/m2 who have impaired fasting glucose (between 5.5-7mmol/l) and HbA1C between 5.7% and 6.5%,
* Exclusion Criteria:• Type 1 or Type 2 Diabetes
* Gained or lost ≥ 3kg weight in the past three months
* Taken prescription medicines having an impact on metabolism, appetite regulation, glucose homeostasis and hormonal regulation
* Taken any dietary supplements in the last 6 months
* Any chronic illness
* Cardiovascular disease
* Excess alcohol intake
* Current smokers
* Any gastrointestinal disorder e.g. Crohn's disease, coeliac disease or irritable bowel syndrome
* A history of drug or alcohol abuse in the last 2 years
* Pregnancy (all women of child bearing age will undergo a pregnancy test).
* Pancreatitis
* Use of medications likely to interfere with glucose metabolism, appetite regulation, hormonal balance.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01692002
Study Brief:
Protocol Section:
NCT01692002