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Completed

NCT Number: NCT01271062

Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Bariatric Surgery Candidate Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Endocrinology and Nuclear Medicine, Department of Internal Medicine, MEdical University of Graz, Austria, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years
  • indication forbariatric surgery or non-bariatric abdominal surgery

Exclusion criteria

  • Pregnancy

Treatment and study plan

Gastric bypass surgery

Procedure

Abdominal surgery

Procedure

very low caloric diet

Behavioral

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. • Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis

    Time frame: 10 days after gastric bypass

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Collaborators

  • European Foundation for the Study of Diabetes
  • Medical University of Graz

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2011
Registry last updated
Mar 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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