Evaluation of the Neuro-endocrine Response to Post-prandial Hyperinsulinaemic Hypoglycaemia. (NCT04334161) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Neuro-endocrine Response to Post-prandial Hyperinsulinaemic Hypoglycaemia.
Switzerland32 participantsStarted 2020-10-02
Plain-language summary
The primary objective of this study is to assess the neuro-endocrine response to hypoglycaemia in PHH vs. non-PHH post-gastric bypass individuals.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Glucagon response during the 20min hypoglycaemic period as defined using the area under the concentration curve (AUC)
Timeframe: 20 minutes of the hypoglycaemic period (from 150 to 170 minutes after the oral glucose load)