Clinical trials: Post-Bariatric Hypoglycemia
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
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 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
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
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
Post-bariatric Hypoglycaemia, Roux-en-Y Gastric Bypass
Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 2
The overall aim of this study is to develop a sustainable hypoglycemia correction strategy.
- Trial name
- PBH Forecast (NCT05250271)
- Testing
- 15 g dextrose, 5 g dextrose, Protein bar
- Where
- Switzerland
- Volunteers
- 8 people
- Sponsor
- Lia Bally
Hyperinsulinemia Hypoglycemia
Evaluation of Single Ascending Doses of Subcutaneous Exendin 9-39 in Patients With Post-Bariatric Hypoglycemia
This study is designed to evaluate the safety, efficacy, and pharmacokinetic profile of single ascending doses of exendin 9-39 administered by subcutaneous route in subjects with post-bariatric hypoglycemia.
- Trial name
- NCT02996812
- Testing
- Exendin (9-39)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Tracey McLaughlin
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.
Bariatric Surgery
Understanding Hypoglycaemia After Bariatric Surgery
Postprandial hyperinsulinaemic hypoglycaemia is an increasingly recognized adverse side effect of bariatric surgery. Affected individuals experience low glucose levels 1-3 hours after intake of meals, accompanied by symptoms such…
- Trial name
- HYPOBAR1 (NCT03609632)
- Testing
- Dietary Supplement: Glucose
- Where
- Switzerland
- Volunteers
- 16 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Bariatric Surgery, Hypoglycemia
Assessing Insulin Turnover Using an In-vivo Deuterated Water Experiment.
The primary objective of this study is to observe the kinetics of pre-stored and de-novo synthesized insulin that is secreted into the circulation using an in-vivo heavy water (D2O) labelling experiment in patients with…
- Conditions
- Bariatric Surgery, Hypoglycemia, Gastric Bypass
- Trial name
- DEEP1A (NCT04332289)
- Testing
- Heavy water experiment
- Where
- Switzerland
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Lia Bally
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
Postbariatric Hypoglycemia
Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects
This clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (PBH).
- Trial name
- NCT05541939
- Testing
- Mizagliflozin
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Vogenx, Inc.
Hypoglycemia, Hypoglycemia, Reactive
Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia
The purpose of the study is to determine how blood sugar levels in individuals with and without hypoglycemia after bariatric surgery respond to different doses of glucagon, a hormone that is usually present in your body that…
- Conditions
- Hypoglycemia, Hypoglycemia, Reactive, Bariatric Surgery
- Trial name
- NCT06986603
- Testing
- Glucagon for Injection (Fresenius Kabi USA)
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Joslin Diabetes Center
Roux-en-Y Gastric Bypass, Postprandial Hypoglycemia
Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.
The primary objective of this study is to assess the effect of the natural course of postprandial hypoglycemia vs. a postprandial euglycaemic condition on driving performance in individuals with confirmed postprandial…
- Conditions
- Roux-en-Y Gastric Bypass, Postprandial Hypoglycemia, Driving Impaired
- Trial name
- DEEP1C (NCT04330196)
- Testing
- Oral glucose tolerance test
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Lia Bally
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, 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
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
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
Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia
Treatment of Post-bariatric Hypoglycaemia
This is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, single-centre phase II study aiming to evaluate the efficacy, safety and tolerability of self-administered subcutaneous 120 µg…
- Trial name
- SHERRY (NCT04836273)
- Testing
- Dasiglucagon, HyoPen
- Where
- Denmark
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Filip Krag Knop
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