Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB)

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Roux-en-Y gastric bypass (RYGB) is the most common surgical procedure for morbid obesity. However, it can present serious late complications, like postprandial hyperinsulinemic hypoglycemia (PHH). Recent data suggested an increase in intestinal SGLT1 after RYGB. However, there are no data on the inhibition of SLGT1 to prevent PHH in patients with prior RYBG.

Objectives: To evaluate in patients that present PHH after RYGB: a) the effect of canagliflozin 300mg on the response to 100g glucose overload (OGTT); b) the pancreatic response after intra-arterial calcium stimulation.

Material and methods: Prospective pilot study, including patients with PHH after RYGB, matched by age and gender with healthy controls. Basal OGTT and after 2-weeks of daily 300mg of canagliflozin will be performed. In addition, venous sampling after intra-arterial calcium stimulation of the pancreas will be performed.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Treatments: Canagliflozin

Criteria

Inclusion Criteria:

• Patients diagnosed with PHH following Roux-en-Y-gastric by-pass, by means of 100g Glucose OGTT. Plasma glucose <50mg/dl.

• Patients that during any time of the OGTT present at least one value of plasma glucose >200mg/dl, besides hypoglycemia

Exclusion Criteria:

• Patients unwilling to take canagliflozin 300mg

• Patients that present with PHH following other bariatric surgery techniques