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

Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass: Comparing Tissue Glucose Levels Between Two Surgical Bypass Methods - a Prospective Study

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

Study Overview

• Status: Unknown
• Conditions: Hypoglycemia; Roux-en-y Gastric Bypass; Continuous Glucose Monitoring
• Intervention / Treatment: Device: Continuous glucose monitoring

• Study Type: Observational
• Enrollment (Anticipated): 68

Contacts and Locations

Study Locations

• Austria
  • Hollabrunn, Austria, 2020
    • Landesklinikum Weinviertel Hollabrunn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Of each bariatric-metabolic operation we plan to include 34 patients. Of these 34 patients we plan to include also patients in each group with a diagnosed Diabetes mellitus type II at the time of operation (defined by either HbA1c >6.5 or any medication or impaired fasting blood glucose level)

1. Roux-en-y gastric bypass with long ang narrow pouch ("long pouch RYGB")
2. Roux-en-y gastric bypass with short and broad pouch ("short pouch RYGB")

Patients in the two RYGB groups will be matched for sex, age, comorbidities and BMI at the time of operation.

Description

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
long pouch RYGB; Patients with the variation of a long and narrow pouch (hypothesis: slower transit of food)	Device: Continuous glucose monitoring; see arm/group descriptions
short pouch RYGB; Patients with the variation of a short and wide pouch (hypothesis: faster pouch emptying as compared with long and narrow pouch)	Device: Continuous glucose monitoring; see arm/group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue glucose levels	Difference in tissue glucose levels after the two variations of the Roux-en-y Gastric bypass	6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tissue vs. blood glucose levels	Comparison of tissue and blood glucose levels	1 day

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Medtronic
• Investigators: Principal Investigator: Gerhard Prager, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: metabolic surgery
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: 2235/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No