Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery
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ClinicalTrials.gov Identifier: NCT01271062 |
Recruitment Status :
Completed
First Posted : January 6, 2011
Last Update Posted : March 7, 2013
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Sponsor:
Cantonal Hospital of St. Gallen
Collaborators:
European Foundation for the Study of Diabetes
Medical University of Graz
Information provided by (Responsible Party):
Bernd Schultes, Cantonal Hospital of St. Gallen
Tracking Information | |||||||
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First Submitted Date ICMJE | January 5, 2011 | ||||||
First Posted Date ICMJE | January 6, 2011 | ||||||
Last Update Posted Date | March 7, 2013 | ||||||
Study Start Date ICMJE | October 2009 | ||||||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function [ Time Frame: 10 days after gastric bypass ] | ||||||
Original Primary Outcome Measures ICMJE |
Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function | ||||||
Change History | Complete list of historical versions of study NCT01271062 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery | ||||||
Official Title ICMJE | Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery in Severely Obese Patients With Type 2 Diabetes | ||||||
Brief Summary | Bariatric operations such as the gastric bypass procedure provide a unique in vivo model of improvement of pathological beta cell function. The presented double-centre study aims to comprehensively investigate different aspects of beta cell function in patients with type 2 diabetes (T2DM) with a wide range of disease duration after gastric bypass. In parallel, our project will address the aspects of changes in enteroinsular and adipoinsular axes as well as the early and late changes of other defined parameters after gastric bypass surgery. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
55 | ||||||
Original Estimated Enrollment ICMJE |
115 | ||||||
Actual Study Completion Date ICMJE | December 2012 | ||||||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Austria, Switzerland | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01271062 | ||||||
Other Study ID Numbers ICMJE | EKSG 09/061/2B | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Bernd Schultes, Cantonal Hospital of St. Gallen | ||||||
Study Sponsor ICMJE | Cantonal Hospital of St. Gallen | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Cantonal Hospital of St. Gallen | ||||||
Verification Date | March 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |