- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04720859
Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB) (CANA-PHH-RYGB)
Canagliflozin: a New Therapeutic Option in Patients That Present Postprandial Hyperinsulinemic Hypoglycemia After Roux-en-Y-gastric By-pass
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andreea Ciudin, Prof.
- Phone Number: 6591 697817352
- Email: aciudin@vhebron.net
Study Contact Backup
- Name: Enzamaria Fidilio, MD
- Email: enzamaria.fidilio@vhir.org
Study Locations
-
-
-
Barcelona, Spain, 08035
- Recruiting
- Andreea Ciudin
-
Sub-Investigator:
- Enzamaria Fidilio, MD
-
Sub-Investigator:
- Marta Sanchez, MD
-
Contact:
- Enzamaria Fidilio, MD
- Email: enzamaria.fidilio@vhir.org
-
Contact:
- Andreea Ciudin, Prof
- Phone Number: 6591 697817352
- Email: aciudin@vhebron.net
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Sub-Investigator:
- Irene Hernandez, BS
-
Sub-Investigator:
- Efrain Cordero, BS
-
Sub-Investigator:
- Marta Comas, Nutritionist
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Sub-Investigator:
- Carla Gonzalez, MD
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Sub-Investigator:
- Natividad Lopez, Nurse
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Sub-Investigator:
- Ramon Vilallonga, Prof
-
Sub-Investigator:
- Cristina Hernandez, Prof
-
Sub-Investigator:
- Rafael Simo, Prof
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with PHH following Roux-en-Y-gastric bypass (cases)
Patients diagnosed with PHH following Roux-en-Y-gastric bypass.
|
Patients diagnosed with PHH following bariatric surgery by 100g glucose OGTT were prescribed 300mg canagliflozin during two weeks.
100g glucose OGTT response was evaluated after canagliflozin treatment.
|
No Intervention: Healthy individuals (controls)
Healthy normoweight individuals, matched by age and gender with the cases.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of nesidioblastosis
Time Frame: 30 minutes
|
By evaluating pancreatic response to intra-arterial calcium stimulation.
The right femoral artery is catheterized with another 4.1 Fr, followed by standard pancreatic arteriography, with selective injections of nonionic contrast agent into the superior mesenteric artery, gastroduodenal artery, splenic artery and common hepatic artery.
Following each selective arteriogram, 10% calcium gluconate solution is diluted with normal saline into a 5 mL bolus and injected into the selective artery at a dose of 0.010-0.025
mEq Ca2+/kg.
A >2-fold gradient in insulin concentration at 30, 60, 90 or 120 seconds after the arterial calcium injection and baseline in any of the superior mesenteric artery, gastroduodenal artery, splenic artery and common hepatic artery was defined as a positive response for endogenous hyperinsulinism.
|
30 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andreea Ciudin, Prof., Vall Hebron University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Infant, Newborn, Diseases
- Hyperinsulinism
- Pancreatic Diseases
- Hypoglycemia
- Congenital Hyperinsulinism
- Nesidioblastosis
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Sodium-Glucose Transporter 2 Inhibitors
- Canagliflozin
Other Study ID Numbers
- PR(AG)84/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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