Postprandial HypoglycemiaCANA-PHH-RYGBNCT04720859
Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB)
A study testing Canagliflozin 300 MG Oral Tablet in people with Postprandial Hypoglycemia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hypoglycemia
- What is being tested?
- Canagliflozin 300 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jan 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Patients unwilling to take canagliflozin 300mg
- Patients that present with PHH following other bariatric surgery techniques
Trial locations and contacts
1 site in 1 country.
Enzamaria Fidilio, MD contact
Spain1 site, 1 recruiting
- Recruiting
Andreea Ciudin
Barcelona, 08035
Andreea Ciudin, Prof, 697817352 ext. 6591, aciudin@vhebron.net
Enzamaria Fidilio, MD, enzamaria.fidilio@vhir.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Postprandial Hypoglycemia
- Being tested
- Canagliflozin 300 MG Oral Tablet
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin 300 MG Oral TabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PHH following Roux-en-Y-gastric bypass (cases) | Experimental | Patients diagnosed with PHH following Roux-en-Y-gastric bypass. Receives: Drug: Canagliflozin 300 MG Oral Tablet |
| Healthy individuals (controls) | No intervention | Healthy normoweight individuals, matched by age and gender with the cases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 180 minutes
Secondary outcomes (1)
Presence of nesidioblastosis
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start5 Jan 2018
- Primary completion20 Dec 2019
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention arm in patients that present postprandial hypoglycemia following gastric by-pass and a control group of healthy subjects without intervention.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreea Ciudin, Hospital Universitari Vall d'Hebron Research Institute
- Investigators
- Andreea Ciudin, Prof., Principal investigator, Vall Hebron University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720859
- Sponsor's protocol ID
- PR(AG)84/2018
- Acronym
- CANA-PHH-RYGB
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canagliflozin: a New Therapeutic Option in Patients That Present Postprandial Hyperinsulinemic Hypoglycemia After Roux-en-Y-gastric By-pass
- ClinicalTrials.gov ID
- NCT04720859
- Acronym / sponsor ID
- CANA-PHH-RYGB / PR(AG)84/2018
- Conditions
- Postprandial Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Intervention arm in patients that present postprandial hypoglycemia following gastric by-pass and a control group of healthy subjects without intervention.
| Arm | Type | Receives |
|---|---|---|
| Patients with PHH following Roux-en-Y-gastric bypass (cases) | Experimental | Drug: Canagliflozin 300 MG Oral TabletPatients diagnosed with PHH following Roux-en-Y-gastric bypass. |
| Healthy individuals (controls) | No intervention | –Healthy normoweight individuals, matched by age and gender with the cases. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients unwilling to take canagliflozin 300mg
- Patients that present with PHH following other bariatric surgery techniques
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canagliflozin 300 MG Oral TabletPatients 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. | Drug | Patients with PHH following Roux-en-Y-gastric bypass (cases) |
Primary outcome
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.
1 secondary outcome
Presence of nesidioblastosis
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enzamaria Fidilio, MD contact
Andreea Ciudin, Prof. principal investigator
Vall Hebron University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canagliflozin 300 MG Oral Tablet in people with Postprandial Hypoglycemia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreea Ciudin, Prof. (697817352 ext. 6591, aciudin@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.