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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT03609632
Eligibility Criteria:
Inclusion Criteria:
* Gastric bypass (RYGB) surgery performed ≥ 6 months ago
* Confirmed postprandial hypoglycaemia (continuous glucose monitoring or plasma glucose), with at least 2 episodes of Whipple's triad (symptoms, capillary of interstitial glucose ≤3.1mmol/L, symptom resolution by carbohydrate intake) ≤3 months ago
* Normal glucose control at recruitment and absence of (pre)diabetes before bariatric surgery
* Capacity to give informed consent
Exclusion Criteria:
* Fasting hypoglycaemia suggesting hyperinsulinism of different aetiology
* Use of medication that influence glucose metabolism
* Bariatric procedures other than RYGB
* Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
* Moderate to severe chronic kidney disease
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03609632
Study Brief:
Protocol Section:
NCT03609632