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

NCT04172116 | Unknown

• 1 other identifier: 2235/2018
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

metabolic surgery

Outcome Measures

Primary Outcomes (1)

• Tissue glucose levels

  Difference in tissue glucose levels after the two variations of the Roux-en-y Gastric bypass

  6 days

Secondary Outcomes (1)

• tissue vs. blood glucose levels

  1 day

Study Arms (2)

long pouch RYGB

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

Device: Continuous glucose monitoring

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

Interventions

Continuous glucose monitoring DEVICE

see arm/group descriptions

long pouch RYGB; short pouch RYGB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Medtronic: collaborator

Study Sites (1)

Landesklinikum Weinviertel Hollabrunn

Hollabrunn, 2020, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood chemistry testing for blood glucose levels

MeSH Terms

Conditions

Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Gerhard Prager, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerhard Prager, MD

CONTACT

0043 40400 56210; gerhard.prager@muw.ac.at

Julia Jedamzik, MD

CONTACT

0043 40400 56210; julia.jedamzik@muw.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.Doz.Prof. Dr.

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)