Clinical trials: Post Bariatric Hypoglycemia
Post-bariatric Hypoglycaemia, Roux-en-Y Gastric Bypass
Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 1
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 (NCT05212207)
- Testing
- CGM, smartwatch, and electronic diary
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- Lia Bally
Hypoglycemia, Complications of Bariatric Procedures
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe…
- Trial name
- NCT02733588
- Testing
- G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Xeris Pharmaceuticals
Roux-en-y Gastric Bypass, Post Prandial Hypoglycemia
Evaluation of the Neuro-endocrine Response to Post-prandial Hyperinsulinaemic Hypoglycaemia.
The primary objective of this study is to assess the neuro-endocrine response to hypoglycaemia in PHH vs. non-PHH post-gastric bypass individuals.
- Trial name
- DEEP1B (NCT04334161)
- Testing
- Administration of glucose and controlled induction of hypoglycaemia.
- Where
- Switzerland
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Lia Bally
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
Hypoglycemia, Reactive, Hypoglycemia
Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery
The purpose of this study is to see if the use of a continuous glucose monitor (CGM) by people who experience low blood sugars (hypoglycemia) after gastric surgery can help reduce the number and severity of low blood sugar…
- Trial name
- NCT03353415
- Testing
- Dexcom CGM masked, Dexcom CGM unmasked
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Joslin Diabetes Center
Sleeve Gastrectomy
Alcohol After Bariatric Surgery 2
The goal of this observational study is to learn how the body processes ingested alcohol and how alcohol affects mood and blood sugar in both men and women after undergoing sleeve gastrectomy.
- Trial name
- ABS2 (NCT06257771)
- Testing
- Alcohol (Ethanol)
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- University of Illinois at Urbana-Champaign
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
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
Bariatric Surgery (Gastric Bypass)
Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?
Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing higher peak blood glucose concentration early after meal intake.
- Trial name
- NCT02665715
- Testing
- Low carbohydrate meals, Standard carbohydrate meals
- Where
- Denmark
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Amirsalar Samkani
Hypoglycemia, Cognition
Cognition in Patients With Hypoglycemia, Without Diabetes
The purpose of this study is to determine if there are differences in cognitive function (thinking) in individuals who have recurrent hypoglycemia (low blood sugars) following Roux-en-Y gastric bypass, compared with individuals…
- Trial name
- NCT04430582
- Testing
- Cognitive Assessment (not diagnostic), ECG
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Joslin Diabetes Center
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.
Post-bariatric Surgery
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism. The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the…
- Trial name
- GLP-1 (NCT01803451)
- Testing
- exendin-(9-39), exendin -(9-39)
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center at San Antonio
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
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
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
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
Acquired Hyperinsulinemic Hypoglycemia
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic…
- Trial name
- NCT04652479
- Testing
- Avexitide
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Dr. Tracey McLaughlin, MD
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
Hyperinsulinemic Hypoglycemia
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial…
- Trial name
- NCT03770637
- Testing
- Glucagon RTU
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Xeris Pharmaceuticals
Hypoglycemia
Mechanisms of Post-Bariatric Hypoglycemia
Post-bariatric hypoglycemia (PBH) is an increasingly recognized syndrome that is incompletely understood. The purpose of this study is to increase our level of understanding by investigating mechanisms contributing to this…
- Trial name
- NCT04428866
- Testing
- Continuous Glucose Monitoring, activity monitor, Mixed meal tolerance test
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Joslin Diabetes Center