Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass

• Conditions: Roux-en-y Gastric Bypass; Continuous Glucose Monitoring; Hypoglycemia
• Interventions: Device: Continuous glucose monitoring

• Registration Number: NCT04172116
• Lead Sponsor: Medical University of Vienna

Brief Summary

This study evaluates the difference in post prandial tissue glucose levels between two variation of Roux-en-Y Gastric bypass by continuous glucose monitoring.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Study First Posted: 2019-11-21
• Last Update Posted: 2019-11-21
• Study Start: 2020-01
• Primary Completion: 2020-12
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Patients who underwent bariatric-metabolic surgery at the Medical University of Vienna in the years 2012-2016 for the "long and narrow" pouch group
2. Patients who underwent bariatric-metabolic surgery at the Clinic of Hollabrunn in the years 2010- 2012 for the "short and wide" pouch group
3. Patients on oral medication for diabetes mellitus (for subgroup assessment)
4. Stable weight (not more than + 15kg from lowest weight postoperatively)
5. Stable BMI

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Exclusion Criteria

1. Unable to give written informed consent
2. Patients with methods other than RYGB
3. Reoperation within the observed period
4. Any intervention changing pouch size or diameter of the anastomosis after the initial operation
5. Known allergy to oral contrast agent
6. Any regular intake of medication interfering with blood glucose levels

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
short pouch RYGB	Continuous glucose monitoring	Patients with the variation of a short and wide pouch (hypothesis: faster pouch emptying as compared with long and narrow pouch)
long pouch RYGB	Continuous glucose monitoring	Patients with the variation of a long and narrow pouch (hypothesis: slower transit of food)

Primary Outcome Measures

Name	Time	Method
Tissue glucose levels	6 days	Difference in tissue glucose levels after the two variations of the Roux-en-y Gastric bypass

Secondary Outcome Measures

Name	Time	Method
tissue vs. blood glucose levels	1 day	Comparison of tissue and blood glucose levels

Trial Locations

Locations (1)

Landesklinikum Weinviertel Hollabrunn; 🇦🇹 Hollabrunn, Austria