Clinical trials: Post-bariatric Hypoglycaemia
Bariatric Surgery
Glycemic Patterns After Bariatric Surgery and High Glycemic Variability and Hypoglycemia Unawareness Risk Factors
To study the glycemic patterns of patients undergoing bariatric surgery and what are the risk factors capable of predicting episodes of unnoticed hypoglycemia and high glycemic variability, evaluating patients who underwent…
- Trial name
- NCT05728320
- Testing
- Glucose monitoring with flash glucose monitor
- Where
- Brazil
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Rio de Janeiro State University
Post-Bariatric Hypoglycemia
Dietary, Medication, and Endoscopic Interventions for Post-Bariatric Hypoglycemia
Post-bariatric hypoglycemia (PBH) is a complication of upper gastrointestinal surgery that causes recurrent episodes of low blood sugar after eating and can substantially impair quality of life.
- Trial name
- NCT07878494
- Testing
- Dietary Intervention, GLP-1 receptor agonist or Dual GIP/GLP-1 receptor agonist, Transoral Outlet Reduction (TORe)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Stanford University
Postbariatric Hypoglycemia
Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions.
- Trial name
- NCT05721729
- Testing
- Mizagliflozin
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Vogenx, Inc.
Bariatric Surgery, Hormonal Response
Comparison of Hormonal Response to a Mixed-Meal Tolerance Test After Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy With Duodenojejunal Bypass in Patients With Super Morbid Obesity
Obesity is a major global health problem. Bariatric surgery is the most effective treatment, leading to substantial weight loss and improvement in obesity-related comorbidities.
- Conditions
- Bariatric Surgery, Hormonal Response, Post Bariatric Hypoglycemia
- Trial name
- CU BYPASS-DJB (NCT07747779)
- Testing
- Sleeve gastrectomy with duodenojejunal bypass, Roux-en-Y gastric bypass
- Where
- Thailand
- Volunteers
- 32 people
- Sponsor
- Chulalongkorn University
Obesity, Hypoglycemia
Etiology, Assessment and Treatment of Post-gastric Bypass Severe Hypoglycemia
With increasing rates of obesity the number of anti-obesity operations performed is increasing; one of the most common is gastric bypass.
- Conditions
- Obesity, Hypoglycemia, Surgery
- Trial name
- NCT01865760
- Testing
- Oral Glucose tolerance test (OGGT), Liquid mixed meal, Octreotide
- Where
- Denmark
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Hypoglycemia
GLP1R-imaging in Hypoglycemia
Hyperinsulinemic hypoglycemia (HH) is a rare complication that occurs 1 to 5 years after gastric bypass surgery. The underlying mechanism of this complication is not yet completely understood.
- Trial name
- NCT03182192
- Testing
- 68Ga-NODAGA-exendin-4 PET/CT
- Where
- 2 sites in Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Post-Bariatric Hypoglycemia
Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at…
- Trial name
- NCT04615546
- Testing
- Use of Continuous Glucose Monitor (CGM), Use of "Cardea Solo" monitoring
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Stanford University
Post-bariatric Hypoglycemia
Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia
To assess the efficacy of a closed loop glucagon system to prevent and treat hypoglycemia occurring in patients with Post-Bariatric Hypoglycemia (PBH) in response to meals and exercise.
- Trial name
- NCT03255629
- Testing
- glucagon, Closed loop glucagon pump
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Joslin Diabetes Center
Post Bariatric Hypoglycemia
Avexitide for Treatment of Post-Bariatric Hypoglycemia
AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB).
- Trial name
- LUCIDITY (NCT06747468)
- Testing
- Avexitide
- Where
- 21 sites in United States
- Volunteers
- 75 people
- Sponsor
- Amylyx Pharmaceuticals Inc.
Post-Bariatric Hypoglycemia
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods 19 weeks for the Core Phase.
- Trial name
- PASIPHY (NCT05928390)
- Testing
- Pasireotide Diaspartate
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 93 people
- Sponsor
- RECORDATI GROUP
Post-bariatric Hypoglycemia
An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia
The Expanded Access Program will provide access to avexitide for people with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) who meet the eligibility criteria for this program.
- Trial name
- NCT07582874
- Testing
- Avexitide
- Where
- 4 sites in United States
- Sponsor
- Amylyx Pharmaceuticals Inc.
Hypoglycemia, Roux-en-Y Gastric Bypass
The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia
The goal of this pilot study is to evaluate the magnitude of changes in glucose and hormone levels in response to structured exercise in the fasting state in individuals with post-bariatric hypoglycemia (PBH).
- Conditions
- Hypoglycemia, Roux-en-Y Gastric Bypass, Post-bariatric Hypoglycemia, Physical Activity
- Trial name
- NCT05560789
- Testing
- Physical activity (cycling on a stationary bicycle ergometer or walking on a treadmill)
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Joslin Diabetes Center
Post Bariatric Hypoglycemia
Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous exendin (9-39) in subjects with post-bariatric hypoglycemia.
- Trial name
- NCT02771574
- Testing
- Lyo avexitide, Liq avexitide
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Tracey McLaughlin
Post-bariatric Hypoglycaemia, Roux-en-Y Gastric Bypass
Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 3
The overall aim of this study is to prevent hypoglycemic events in patients with hypoglycemia after a meal and to develop a sustainable hypoglycemia correction strategy.
- Trial name
- PBH Forecast (NCT05216926)
- Testing
- Timing of preventive action based on prediction model, Hypoglycaemia treatment at hypoglycaemia (usual care)
- Where
- Switzerland
- Volunteers
- 60 people
- Sponsor
- Lia Bally
Hypoglycemia, Hypoglycemia, Reactive
Post-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH)
In this study, the investigators will determine (a) whether metabolism (secretion and turnover) of glucagon is altered in patients with PBH, (b) whether this is affected by a meal, (c) whether PBH affects the ability of the body…
- Conditions
- Hypoglycemia, Hypoglycemia, Reactive, Bariatric Surgery
- Trial name
- NCT07818707
- Testing
- Glucagon for Injection (Fresenius Kabi USA), [6,6-2H2] glucose, [13C9, 15N1]-glucagon
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Joslin Diabetes Center
Hypoglycemia
Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.
- Trial name
- NCT02550145
- Testing
- Exendin (9-39)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Tracey McLaughlin
Hypoglycemia
Post Bariatric Closed Loop Glucagon Trial
This study is to test our automated hypoglycemia prevention and treatment device (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that are experiencing symptoms of hypoglycemia.
- Trial name
- NCT02966275
- Testing
- Glucagon-only bionic pancreas - glucagon
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Obesity (Disorder)
Continuous Glucose Monitoring in Metabolic Surgery
We will recruit 20 severely obese participants at Metamor Institute. Participants with obesity who are eligible for MBS will be randomized to either CGM group or self-monitoring of blood glucose (SMBG) group before the surgery…
- Trial name
- NCT07095972
- Testing
- Abbot Freestyle Libre CGM
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Pennington Biomedical Research Center
Obesity, Hypoglycemia Post Gastric Bypass Surgery
GLP1R-imaging in Post-RYGB Hypoglycemia
In order to evaluate the difference in beta cell mass in patients with and without hyperinsulinemic hypoglycemia after Roux en Y gastric bypass (RYGB) investigators aim to compare quantitative PET imaging of the pancreas between…
- Conditions
- Obesity, Hypoglycemia Post Gastric Bypass Surgery, Hyperinsulinemic Hypoglycemia
- Trial name
- NCT05597475
- Testing
- GLP-1R PET
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Rijnstate Hospital
Hypoglycemia, Glucose Metabolism Disorders
Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects
- Trial name
- NCT04824872
- Testing
- Dasiglucagon
- Sponsor
- Zealand Pharma