Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 2

NCT05250271 | Completed

• 1 other identifier: PBH Forecast (WP 2)
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this study is to develop a sustainable hypoglycemia correction strategy.

Conditions

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

Keywords

Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• Time in glucose target range

  The primary endpoint is time in glucose target range (plasma glucose 3.9-5.5 mmol/L).

  During 40 minutes after hypoglycaemia correction

Secondary Outcomes (13)

• Percentage of time with plasma glucose <3.0 mmol/L

  During 40 minutes after hypoglycaemia correction

• Percentage of time with plasma glucose <3.9 mmol/L

  During 40 minutes after hypoglycaemia correction

• Percentage of time with plasma glucose >5.5 mmol/L

  During 40 minutes after hypoglycaemia correction

• Percentage of time with plasma glucose >10.0 mmol/L

  During 40 minutes after hypoglycaemia correction

• Percentage of time with sensor glucose <3.0 mmol/L

  During 150 minutes after hypoglycaemia correction

Study Arms (6)

Treatment sequence 1

OTHER

Sequence of the treatments: Glucose (15g) - Glucose (5g) -Protein bar

Other: 15 g dextrose; Other: 5 g dextrose; Other: Protein bar

Treatment sequence 2

OTHER

Sequence of the treatments: Glucose (15g) - Protein bar - Glucose (5g)

Other: 15 g dextrose; Other: 5 g dextrose; Other: Protein bar

Treatment sequence 3

OTHER

Sequence of the treatments: Glucose (5g) - Glucose (15g) - Protein bar

Other: 15 g dextrose; Other: 5 g dextrose; Other: Protein bar

Treatment sequence 4

OTHER

Sequence of the treatments: Glucose (5g) - Protein bar - Glucose (15g)

Other: 15 g dextrose; Other: 5 g dextrose; Other: Protein bar

Treatment sequence 5

OTHER

Sequence of the treatments: Protein bar - Glucose (15g) - Glucose (5g)

Other: 15 g dextrose; Other: 5 g dextrose; Other: Protein bar

Treatment sequence 6

OTHER

Sequence of the treatments: Protein bar - Glucose (5g) - Glucose (15g)

Other: 15 g dextrose; Other: 5 g dextrose; Other: Protein bar

Interventions

15 g dextrose OTHER

15 g dextrose tablets

Treatment sequence 1; Treatment sequence 2; Treatment sequence 3; Treatment sequence 4; Treatment sequence 5; Treatment sequence 6

5 g dextrose OTHER

5 g dextrose tablets

Treatment sequence 1; Treatment sequence 2; Treatment sequence 3; Treatment sequence 4; Treatment sequence 5; Treatment sequence 6

Protein bar OTHER

5 g carbohydrates + 10 g protein

Treatment sequence 1; Treatment sequence 2; Treatment sequence 3; Treatment sequence 4; Treatment sequence 5; Treatment sequence 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lia Bally: lead
• University of Padova: collaborator

Study Sites (1)

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

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Lia Bally, Prof. Dr. med. et phil.

  Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, lnselspital, Bern University Hospital, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to sensor and plasma glucose.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Nutrition, Metabolism and Obesity and Head of Research

Model Details: 3-period crossover design

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 22, 2022
• Study Start: January 18, 2022
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After study completion, 10 years
• Access Criteria: Data will be shared after written inquiry and approval by the principal investigator.

Locations

CH (1)