Clinical trials: Post-Bariatric Hypoglycemia
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
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
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
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 and the Gut Microbiome
This study is designed to evaluate individuals who are currently experiencing symptoms of hypoglycemia, in order to discern correlations between microbiome composition and patterns of postprandial glycemia.
- Trial name
- NCT03385707
- Where
- United States
- Volunteers
- 28 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
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
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
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
Postbariatric Hypoglycemia
Effect of Mizagliflozin on Hypoglycemia in Patients With Post-Bariatric Hypoglycemia
VGX-001-013 (EMERGE) is a Phase 2b study to evaluate an investigational new drug, mizagliflozin, for safety, tolerability and its ability to prevent low blood sugar in patients with post-bariatric hypoglycemia.
- Trial name
- EMERGE (NCT07760961)
- Testing
- Mizagliflozin 5 mg, Mizagliflozin 10 mg
- Where
- 11 sites in United States
- Volunteers
- 36 people
- Sponsor
- Vogenx, Inc.
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.
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
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
Dumping Syndrome, Post-bariatric Hypoglycemia
Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
Late dumping syndrome is a common complication following Roux-en-Y gastric bypass, characterized by postprandial hypoglycemia with significant impact on patient safety and quality of life.
- Trial name
- iCan3 Dumping (NCT07440706)
- Testing
- Can i3 Continuous Glucose Monitoring System
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- Kaiser Clinic and Hospital
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
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
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
Postprandial Hypoglycemia, Bariatric Surgery
Postprandial Hypoglycemia in Patients After Bariatric Surgery With Empagliflozin and Anakinra - The Hypo-BEAR-Study
The purpose of the study is to investigate whether hypoglycaemia observed after food intake in bariatric patients can be either influenced by an SGLT2 inhibitor, empagliflozin, or via inhibition of inflammation with an human…
- Conditions
- Postprandial Hypoglycemia, Bariatric Surgery, Late Dumping Syndrome
- Trial name
- Hypo-BEAR (NCT03200782)
- Testing
- Empagliflozin, Anakinra
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- University Hospital, Basel, Switzerland
Post Bariatric Surgery, Gastric Bypass
The Effects of Bariatric Surgeries on Glucose Metabolism
The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.
- Conditions
- Post Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy, Hypoglycemia After Gastric Bypass
- Trial name
- NCT02823665
- Testing
- Exendin-(9-39), Atropine
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center at San Antonio