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

Medical University of Vienna

Status: Unknown

Conditions: Hypoglycemia; Continuous Glucose Monitoring; Roux-en-y Gastric Bypass

Treatments: Device: Continuous glucose monitoring

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04172116

2235/2018

Details and patient eligibility

About

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

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

68 participants in 2 patient groups

long pouch RYGB

Description:

Patients with the variation of a long and narrow pouch (hypothesis: slower transit of food)

Treatment:

Device: Continuous glucose monitoring

short pouch RYGB

Description:

Patients with the variation of a short and wide pouch (hypothesis: faster pouch emptying as compared with long and narrow pouch)

Treatment:

Device: Continuous glucose monitoring