Clinical trial NCT04720859: Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB)
Official title: Canagliflozin: a New Therapeutic Option in Patients That Present Postprandial Hyperinsulinemic Hypoglycemia After Roux-en-Y-gastric By-pass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postprandial Hypoglycemia
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention arm in patients that present postprandial hypoglycemia following gastric by-pass and a control group of healthy subjects without intervention.
Primary purpose: TREATMENT

Brief 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.

Detailed description: A prospective opened, placebo uncontrolled, pilot interventional study is performed at the Morbid Obesity Unit of the Vall Hebron University Hospital, including patients that have previously undergone RYGB at our site and were diagnosed with PHH. The control group comprises of healthy normoweight persons matched by age, most of them family members of patients included in the study. The OGTT is performed as follows: a solution of 100g glucose was administered at 8am after 10 hours of fasting. Plasma glucose and serum insulin are measured at minute -5, +30, +60, +120, +180 after the ingestion of the glucose solution. A first OGTT is performed in basal conditions. The control group only will perform the basal OGTT. A value of plasma glucose below 50mg/dl at 60-180 minutes after the administration of the glucose solution is considered positive for PHH. The patients that additionally present a value of plasma glucose\>200mg/dl during the OGTT will be selected for continuing in the study and will be prescribed canagliflozin 300mg orally daily, during 2 weeks. After 2 weeks of canagliflozin treatment, a new OGTT will be performed and, in the patients that sign the additional inform consent, the pancreatic catheterism will be realized.

Eligibility 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

Primary outcomes:
measure: response to OGTT in basal conditions and after treatment with canagliflozin 300 mg in patients with PHH after RYGB
timeFrame: Baseline to 180 minutes
Secondary outcomes:
measure: Presence of nesidioblastosis
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Andreea Ciudin
Study officials:
affiliation: Vall Hebron University Hospital
name: Andreea Ciudin, Prof.
role: PRINCIPAL_INVESTIGATOR
References: