Clinical trials: Post-bariatric Hypoglycemia
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
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.
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
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, 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
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
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
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
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.
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
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
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
Small Gestational Age (SGA), Hypoglycemia After Gastric Bypass
Glycemic Variability During Pregnancy After Bariatric Surgery
Pregnancies after Metabolic and Bariatric Surgery (MBS) are linked to increased incidence of small-for-gestational-age (SGA) neonates.
- Conditions
- Small Gestational Age (SGA), Hypoglycemia After Gastric Bypass, Glycemic Variability
- Trial name
- NCT07731165
- Testing
- Intermittently Scanned Continuous Glucose Monitoring (isCGM)
- Where
- Portugal
- Volunteers
- 47 people
- Sponsor
- Centro Hospitalar Universitário de Santo António
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
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.
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 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, Cerebral Blood Flow
External Carotid Blood Flow in Individuals With Post-Bariatric Hypoglycemia
This is a pilot study (small-scale study) that aims to understand more about how blood flow changes in people who have low blood sugar after bariatric surgery (post-bariatric hypoglycemia) compared to those who have had surgery…
- Trial name
- NCT07082478
- Testing
- in-ear device measuring blood flow
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Joslin Diabetes Center
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
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