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

NCT ID: NCT04172116

Last Updated: 2019-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-01-31

Brief Summary

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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

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Conditions

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Continuous Glucose Monitoring Roux-en-y Gastric Bypass Hypoglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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long pouch RYGB

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

Continuous glucose monitoring

Intervention Type DEVICE

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)

Continuous glucose monitoring

Intervention Type DEVICE

see arm/group descriptions

Interventions

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Continuous glucose monitoring

see arm/group descriptions

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Prager

Univ.Doz.Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Prager, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Landesklinikum Weinviertel Hollabrunn

Hollabrunn, , Austria

Site Status

Countries

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Austria

Central Contacts

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Gerhard Prager, MD

Role: CONTACT

0043 40400 56210

Julia Jedamzik, MD

Role: CONTACT

0043 40400 56210

Facility Contacts

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Phillip Beckerhinn, MD

Role: primary

Franz Hoffer, MD

Role: backup

Other Identifiers

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2235/2018

Identifier Type: -

Identifier Source: org_study_id

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