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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT04334161
Eligibility Criteria:
Inclusion criteria for PHH patients (Group 1):
* Aged ≥18 years
* Roux-en-Y gastric bypass ≥1 year ago
* PHH defined as postprandial plasma or sensor glucose\<3.0mmol/l according to the International Hypoglycaemia Study Group (1) and exclusion of other causes of hypoglycaemia
Inclusion criteria for non-PHH surgical controls (Group 2 and 3):
* Aged ≥18 years
* Roux-en-Y gastric bypass (Group 2) or sleeve gastrectomy (Group 3) ≥1 year ago
* No evidence of PHH
Inclusion criteria for non-PHH non-surgical controls (Group 4):
* Aged ≥18 years
* Absence of any condition or previous surgery known to affect gastro-intestinal integrity and food absorption
Exclusion criteria for all Groups:
* Clinically relevant weight changes (≥5%) within the past 3 months
* Incapacity to give informant consent
* Historical or current diabetes based on HbA1c ≥6.5% without glucose-lowering treatment
* Haemoglobin level below 13.5 g/l
* Ongoing treatment with glucose-lowering drugs, anorectic drugs, steroids or any medications known to affect gastric motility
* Active heart, lung, liver, gastrointestinal, renal or neurological disease
* Inability to follow study procedures
* Pregnancy or breast-feeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04334161
Study Brief:
Protocol Section:
NCT04334161