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Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 3 (PBH Forecast)

Primary Purpose

Post-bariatric Hypoglycaemia, Roux-en-Y Gastric Bypass

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Timing of preventive action based on prediction model
Hypoglycaemia treatment at hypoglycaemia (usual care)
Sponsored by
Lia Bally
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-bariatric Hypoglycaemia focused on measuring Continuous Glucose Monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Post-bariatric surgery patients (Roux-en-Y gastric bypass) with PBH, defined as postprandial plasma or sensor glucose <3.0 mmol/L according to the International Hypoglycaemia Study Group and exclusion of other causes of hypoglycaemia
  • Age ≥18 years

Exclusion Criteria:

  • Inability to give informed consent as documented by signature
  • Pregnant or lactating women
  • Inability or contraindications to undergo the investigated intervention
  • Drugs interfering with blood glucose (e.g. SGLT-2 inhibitors, acarbose) during the time of investigation
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Sites / Locations

  • Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hypoglycemia predicition and preventive treatment

Corrective hypoglycemia treament (at hypogylcemia)

Arm Description

Outcomes

Primary Outcome Measures

Hypoglycaemia
Proportion of participants with hypoglycaemia (nadir plasma glucose <3.0 mmol/L)

Secondary Outcome Measures

Plasma glucose <3.0 mmol/L
Percentage of post-prandial time with plasma glucose <3.0 mmol/L
Plasma glucose <3.9 mmol/L
Percentage of post-prandial time with plasma glucose <3.9 mmol/L
Plasma glucose ≥10.0 mmol/L
Percentage of post-prandial time with plasma glucose ≥10.0 mmol/L
Mean plasma glucose
Mean plasma glucose concentration
Peak plasma glucose
Peak plasma glucose

Full Information

First Posted
January 14, 2022
Last Updated
October 13, 2023
Sponsor
Lia Bally
Collaborators
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT05216926
Brief Title
Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 3
Acronym
PBH Forecast
Official Title
Forecasting and Preventing Post-Bariatric Hypoglycaemia (Work Package 3)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lia Bally
Collaborators
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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 3.4 mmol/L) 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. Recently, CGM devices have become standard tools for glucose monitoring in patients with diabetes. CGM allows measuring glucose levels every 5 min and the continuous access to real-time data offering several approaches for the prediction of glucose levels or associated events. Such solutions empower patients to take proactive decisions before reaching critical glucose levels. Apart from glucose levels, meal information, physical activity or other physiological parameters may augment prediction performance of hypoglycaemic events. While most engineering work focuses on the prediction of hypoglycaemia in the diabetic population, only preliminary work has been done in the PBH population. 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 this study is to prevent hypoglycaemic events in patients with PBH and to develop a sustainable hypoglycaemia correction strategy. The primary objective of WP 3 is to test the efficacy of an intervention for hypoglycaemia prevention that combines a hypoglycaemia prediction model with a preventive nutritional action.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-bariatric Hypoglycaemia, Roux-en-Y Gastric Bypass
Keywords
Continuous Glucose Monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are blinded to to group allocation, sensor and plasma glucose.
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypoglycemia predicition and preventive treatment
Arm Type
Experimental
Arm Title
Corrective hypoglycemia treament (at hypogylcemia)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Timing of preventive action based on prediction model
Intervention Description
Timing of preventive action based on prediction model
Intervention Type
Other
Intervention Name(s)
Hypoglycaemia treatment at hypoglycaemia (usual care)
Intervention Description
Hypoglycaemia treatment at hypoglycaemia (usual care)
Primary Outcome Measure Information:
Title
Hypoglycaemia
Description
Proportion of participants with hypoglycaemia (nadir plasma glucose <3.0 mmol/L)
Time Frame
In the 180 minutes following the beginning of meal intake
Secondary Outcome Measure Information:
Title
Plasma glucose <3.0 mmol/L
Description
Percentage of post-prandial time with plasma glucose <3.0 mmol/L
Time Frame
During 180 minutes following the beginning of meal intake
Title
Plasma glucose <3.9 mmol/L
Description
Percentage of post-prandial time with plasma glucose <3.9 mmol/L
Time Frame
During 180 minutes following the beginning of meal intake
Title
Plasma glucose ≥10.0 mmol/L
Description
Percentage of post-prandial time with plasma glucose ≥10.0 mmol/L
Time Frame
During 180 minutes following the beginning of meal intake
Title
Mean plasma glucose
Description
Mean plasma glucose concentration
Time Frame
During 180 min following onset of meal intake
Title
Peak plasma glucose
Description
Peak plasma glucose
Time Frame
In the 180 min following onset of meal intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Post-bariatric surgery patients (Roux-en-Y gastric bypass) with PBH, defined as postprandial plasma or sensor glucose <3.0 mmol/L according to the International Hypoglycaemia Study Group and exclusion of other causes of hypoglycaemia Age ≥18 years Exclusion Criteria: Inability to give informed consent as documented by signature Pregnant or lactating women Inability or contraindications to undergo the investigated intervention Drugs interfering with blood glucose (e.g. SGLT-2 inhibitors, acarbose) during the time of investigation Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lia Bally, Prof. Dr. med. et phil.
Phone
+41 31 632 36 77
Email
lia.bally@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lia Bally, Prof. Dr. med. et phil.
Organizational Affiliation
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, lnselspital, Bern University Hospital, University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital
City
Bern
State/Province
BE
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lia Bally, Prof. Dr. med. et phil.
Phone
+41 31 632 36 77
Email
lia.bally@insel.ch

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication will be available to other researchers.
IPD Sharing Time Frame
After study completion, 10 years
IPD Sharing Access Criteria
After written inquiry and approval by the principal investigator.

Learn more about this trial

Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 3

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