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

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT04720859
Status
Unknown

Conditions

  • Postprandial Hypoglycemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Jan 5, 2018
Status verified
Jan 2021
Primary completion
Dec 20, 2019
Completion
Dec 31, 2022

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with PHH following Roux-en-Y-gastric bypass (cases)
    Patients diagnosed with PHH following Roux-en-Y-gastric bypass.
  • No Intervention: Healthy individuals (controls)
    Healthy normoweight individuals, matched by age and gender with the cases.

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 ]

Central Contacts