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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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 Bariatric Surgery Candidate | Procedure: gastric bypass surgery Procedure: abdominal surgery Behavioral: very low caloric diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | 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 |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: T2DM patients before gastric bypass surgery
oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.
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Procedure: gastric bypass surgery |
Active Comparator: Non-diabetic patient before gastric bypass surgery
oral glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.
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Procedure: gastric bypass surgery |
Active Comparator: non diabetic patients, non-bariatric abdominal surgery
oral glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery.
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Procedure: abdominal surgery |
Active Comparator: severely obese T2DM patients following a very low caloric diet
oral glucose tolerance test , botnia clamp, before as well after following a very low caloric diet. Very low caloric diet.
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Behavioral: very low caloric diet |
- 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 ]
- OGTT calculations and modelling describing beta cell response to oral glucose load; Insulin and C-peptide areas under the curve (AUCs) during OGTT quantifying the incretin effect. [ Time Frame: 10 days after gastric bypass ]
- • Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis [ Time Frame: 10 days after gastric bypass ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 18 years
- indication forbariatric surgery or non-bariatric abdominal surgery
Exclusion Criteria:
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271062
Austria | |
Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria | |
Graz, Austria, 8036 | |
Switzerland | |
Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland | |
St. Gallen, Switzerland, 9400 |
Principal Investigator: | Bernd Schultes, Prof. | Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switerland | |
Principal Investigator: | Thomas Pieber, Prof. | Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, Medical University of Graz, Austria |
Responsible Party: | Bernd Schultes, Head of Interdisciplinary Obesity Center, Cantonal Hospital of St. Gallen |
ClinicalTrials.gov Identifier: | NCT01271062 History of Changes |
Other Study ID Numbers: |
EKSG 09/061/2B |
First Posted: | January 6, 2011 Key Record Dates |
Last Update Posted: | March 7, 2013 |
Last Verified: | March 2013 |
Resolvment of Diabetes Mellitus, Type 2 gastric bypass |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |