Clinical trials: Hypoglycemia After Gastric Bypass
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
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, Obesity, Morbid
The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery
This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery.
- Trial name
- NCT05011682
- Testing
- Regular diet, 10-point nutrition plan
- Where
- Norway
- Volunteers
- 9 people
- Sponsor
- Helse Nord-Trøndelag HF
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
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
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, Obesity
Treatment of Hypoglycemia Following Gastric Bypass Surgery
Obesity is increasing worldwide and consequently the need for efficient treatment opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed bariatric procedures used in the treatment of severe obesity.
- Conditions
- Hypoglycemia, Obesity, Surgery
- Trial name
- NCT02527993
- Testing
- Glucobay (acarbose), Januvia (sitagliptin), Verapamil HEXAL (verapamil)
- Volunteers
- 11 people
- Sponsor
- Zealand University Hospital
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 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
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
Hyperinsulinemic Hypoglycemia
Post-Gastric Bypass Hypoglycemia
Post-gastric bypass hyperinsulinemic hypoglycemia is a recently described disorder occurring in some patients after gastric bypass surgery for obesity.
- Trial name
- NCT01933490
- Testing
- high carbohydrate test meal, high carbohydrate test meal after pre-treatment with rapid acting aspart insulin, high fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Minnesota
Hypoglycemia Non-Diabetic, Gastric Bypass Surgery
Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery
The goal of this clinical trial is to learn if continuous glucose monitoring works to treat postprandial hypoglycaemia in patients who have undergone gastric bypass surgery.
- Trial name
- HypoSurge (NCT06468865)
- Testing
- Continuous glucose monitor (Dexcom® G7)
- Where
- Norway
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Sykehuset i Vestfold HF
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
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
Post Bariatricsurgery, Hypoglycemia
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss.
- Trial name
- NCT00992901
- Testing
- Exendin-(9-39), Atropine, GLP-1 and GIP
- Where
- 2 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center at San Antonio
Dumping Syndrome, Hypoglycemia, Reactive
Investigating the Impact of the SGLT2 Inhibitor Empagliflozin on Postprandial Hypoglycaemia After Gastric Bypass
Bariatric surgery is an effective anti-obesity treatment providing durable weight loss and profound beneficial effects on glucose metabolism.
- Trial name
- NCT05057819
- Testing
- Empagliflozin 25 MG
- Where
- Switzerland
- Volunteers
- 22 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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.
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