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

Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04172116
• Other study ID #: 2235/2018
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: January 2021

Study information

• Verified date: November 2019
• Source: Medical University of Vienna
• Contact: Gerhard Prager, MD
• Phone: 0043 40400 56210
• Email: gerhard.prager[@]muw.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Continuous Glucose Monitoring
• Hypoglycemia
• Roux-en-y Gastric Bypass

Intervention

Device:
• Continuous glucose monitoring
see arm/group descriptions

Locations

Country	Name	City	State
Austria	Landesklinikum Weinviertel Hollabrunn	Hollabrunn

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Medtronic

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue glucose levels	Difference in tissue glucose levels after the two variations of the Roux-en-y Gastric bypass	6 days
Secondary	tissue vs. blood glucose levels	Comparison of tissue and blood glucose levels	1 day