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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT05404061
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 -70 years.
* Male or female.
* Previous bariatric surgery for obesity and/or diabetes (studies 1 and 2).
* ≥1 year interval after bariatric surgery (studies 1 and 2).
* Awaiting bariatric surgery at the Imperial Weight Centre (study 3)
* Able to give informed consent.
Exclusion Criteria:
* History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer.
* Without access at home to a telephone or other factor likely to interfere with ability to participate reliably in the study.
* Pregnancy or breastfeeding.
* Unable to maintain adequate contraception for the duration of the study and for one month afterwards.
* History of hypersensitivity to any of the components of the subcutaneous infusions.
* Donated blood during the preceding 3 months or intention to do so before the end of the study.
* Any other co-morbidity that would compromise the validity of the study or the safety of the participant such as heart failure or clinically apparent cardiovascular disease.
* Anatomical or endocrinological pathology causing poor weight loss or weight regain
* Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
* Participation in a research study within the last two months.
* Unable to speak English (this is relevant to answering the psychological questionnaires)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05404061
Study Brief:
Protocol Section:
NCT05404061