Canagliflozin: a New Therapeutic Option in Patients That Present Postprandial Hyperinsulinemic Hypoglycemia After Roux-en-Y-gastric By-pass
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- response to OGTT in basal conditions and after treatment with canagliflozin 300 mg in patients with PHH after RYGB
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Patients with PHH following Roux-en-Y-gastric bypass (cases)
Patients diagnosed with PHH following Roux-en-Y-gastric bypass.
Intervention: Canagliflozin 300 MG Oral Tablet (Drug)
Outcomes
Primary Outcomes
response to OGTT in basal conditions and after treatment with canagliflozin 300 mg in patients with PHH after RYGB
Time Frame: Baseline to 180 minutes
The OGTTis performed as follows: a solution of 100g glucose is administered at 8am after 10 hours of fasting. Plasma glucose and serum insulin were measured at minute -5, +30, +60, +120, +180 after the ingestion of the glucose solution. A first OGTT was performed in basal conditions. The control group only performed 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 presented a value of plasma glucose\>200mg/dl during the OGTT were selected for continuing in the study and were prescribed canagliflozin 300mg orally daily, during two weeks, and 100g glucose OGTT was repeated.
Secondary Outcomes
- Presence of nesidioblastosis(30 minutes)
Investigators
Andreea Ciudin
Associated Professor, PhD, MD, Head of the Morbid Obesity Unit
Hospital Universitari Vall d'Hebron Research Institute