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

NCT04720859 | Unknown

• 1 other identifier: PR(AG)84/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• response to OGTT in basal conditions and after treatment with canagliflozin 300 mg in patients with PHH after RYGB

  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 Outcomes (1)

• Presence of nesidioblastosis

  30 minutes

Study Arms (2)

Patients with PHH following Roux-en-Y-gastric bypass (cases)

EXPERIMENTAL

Patients diagnosed with PHH following Roux-en-Y-gastric bypass.

Drug: Canagliflozin 300 MG Oral Tablet

Healthy individuals (controls)

NO INTERVENTION

Healthy normoweight individuals, matched by age and gender with the cases.

Interventions

Canagliflozin 300 MG Oral Tablet DRUG

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.

Patients with PHH following Roux-en-Y-gastric bypass (cases)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients unwilling to take canagliflozin 300mg
• Patients that present with PHH following other bariatric surgery techniques

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Andreea Ciudin

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Hypoglycemia

Interventions

Canagliflozin; Tablets

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Andreea Ciudin, Prof.

  Vall Hebron University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreea Ciudin, Prof.

CONTACT

697817352; aciudin@vhebron.net

Enzamaria Fidilio, MD

CONTACT

enzamaria.fidilio@vhir.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor, PhD, MD, Head of the Morbid Obesity Unit

Model Details: Intervention arm in patients that present postprandial hypoglycemia following gastric by-pass and a control group of healthy subjects without intervention.

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: January 5, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 31, 2022
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)