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

NCT ID: NCT04720859

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-05

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Postprandial Hypoglycemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Intervention arm in patients that present postprandial hypoglycemia following gastric by-pass and a control group of healthy subjects without intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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

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

Group Type EXPERIMENTAL

Canagliflozin 300 MG Oral Tablet

Intervention Type 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.

Healthy individuals (controls)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Canagliflozin 300 MG Oral Tablet

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Andreea Ciudin

Associated Professor, PhD, MD, Head of the Morbid Obesity Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreea Ciudin, Prof.

Role: PRINCIPAL_INVESTIGATOR

Vall Hebron University Hospital

Locations

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Andreea Ciudin

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Andreea Ciudin, Prof.

Role: CONTACT

Phone: 697817352

Email: [email protected]

Enzamaria Fidilio, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Andreea Ciudin, Prof

Role: primary

Enzamaria Fidilio, MD

Role: backup

Other Identifiers

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PR(AG)84/2018

Identifier Type: -

Identifier Source: org_study_id