Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05250271
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2022-01-14
Brief Title:
Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 2
Sponsor:
Lia Bally
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Forecasting and Preventing Post-Bariatric Hypoglycaemia Work Package 2
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBH Forecast
Brief Summary:
The overall aim of this study is to develop a sustainable hypoglycemia correction strategy
Detailed Description:
Obesity is a major global public health concern for which the most effective therapy is bariatric surgery Beyond weight loss bariatric surgery exerts powerful effects on glucose metabolism achieving complete type 2 diabetes remission in up to 70 of cases An exaggeration of these effects however can result in an increasingly recognized metabolic complication known as postprandial hyperinsulinaemic hypoglycaemia or post-bariatric hypoglycaemia PBH The condition manifests 1-3 years after surgery with meal-induced hypoglycaemic episodes Emerging data suggests that PBH is more frequent than previously thought and affects approximately 30 of postoperative patients more commonly after gastric bypass than sleeve gastrectomy Of note asymptomatic PBH is common as shown in studies using continuous glucose monitoring CGM It is known from extensive research in people with diabetes that recurrent episodes of hypoglycaemia impair counter regulatory defences against subsequent events predisposing patients to severe hypoglycaemia
Despite the increasing prevalence of PBH clinical implications in this population are still unclear Anecdotal evidence from patients with PBH suggests a high burden for these patients due to the recurrent hypoglycaemias with possibly debilitating consequences It is well established that even mild hypoglycaemia plasma glucose of 34 mmolL in diabetic and non-diabetic patients impairs various cognitive domains Of note some of the cognitive functions remain impaired for up to 75 min even when the hypoglycaemia is corrected Further concerns exist from observational studies showing associations between PBH during pregnancy and poor foetal growth
Thus it is important to timely detect and treat hypoglycaemia with an intervention that allows quick recovery of glycaemia to a safe level thereby alleviating symptoms and eliminating the risk of potentially hazardous sequelae Current diabetes-inspired guidelines recommend to correct hypoglycaemia with 15-20 g fast-acting carbohydrates preferably glucose However clinical experience with PBH patients shows that the rapid spikes in glycaemia following correction of hypoglycaemia with such proposed strategies may trigger rebound hypoglycaemia in PBH patients However hypoglycaemia correction strategies that are tailored to the specific needs of PBH do not exist currently Previous research suggests that glucose co-ingested with amino acids induces a metabolic environment that could be favourable for PBH patients due to elevated glucagon levels However it currently remains speculative whether combinations of amino acids with glucose could offer more suitable and sustainable PBH correction strategies
Given the potentially hazardous consequences of hypoglycaemia development of hypoglycaemia management strategies to adequately predict and treat critical blood glucose levels in the PBH population are urgently needed Such strategies have to significantly lower the burden of PBH and increase patient safety
The overall aim or the PBH forecast project containing 3 WPs is to prevent hypoglycaemic events in patients with PBH and to develop a sustainable hypoglycaemia correction strategy The primary objective of WP 2 is to test different nutritional strategies for sustainable hypoglycaemia correction eg minimising time spent hypoglycaemic without causing rebound hyper- and hypoglycaemia
Despite the increasing prevalence of PBH clinical implications in this population are still unclear Anecdotal evidence from patients with PBH suggests a high burden for these patients due to the recurrent hypoglycaemias with possibly debilitating consequences It is well established that even mild hypoglycaemia plasma glucose of 34 mmolL in diabetic and non-diabetic patients impairs various cognitive domains Of note some of the cognitive functions remain impaired for up to 75 min even when the hypoglycaemia is corrected Further concerns exist from observational studies showing associations between PBH during pregnancy and poor foetal growth
Thus it is important to timely detect and treat hypoglycaemia with an intervention that allows quick recovery of glycaemia to a safe level thereby alleviating symptoms and eliminating the risk of potentially hazardous sequelae Current diabetes-inspired guidelines recommend to correct hypoglycaemia with 15-20 g fast-acting carbohydrates preferably glucose However clinical experience with PBH patients shows that the rapid spikes in glycaemia following correction of hypoglycaemia with such proposed strategies may trigger rebound hypoglycaemia in PBH patients However hypoglycaemia correction strategies that are tailored to the specific needs of PBH do not exist currently Previous research suggests that glucose co-ingested with amino acids induces a metabolic environment that could be favourable for PBH patients due to elevated glucagon levels However it currently remains speculative whether combinations of amino acids with glucose could offer more suitable and sustainable PBH correction strategies
Given the potentially hazardous consequences of hypoglycaemia development of hypoglycaemia management strategies to adequately predict and treat critical blood glucose levels in the PBH population are urgently needed Such strategies have to significantly lower the burden of PBH and increase patient safety
The overall aim or the PBH forecast project containing 3 WPs is to prevent hypoglycaemic events in patients with PBH and to develop a sustainable hypoglycaemia correction strategy The primary objective of WP 2 is to test different nutritional strategies for sustainable hypoglycaemia correction eg minimising time spent hypoglycaemic without causing rebound hyper- and hypoglycaemia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None