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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01271062
Enrollment
55
Registered
2011-01-06
Start date
2009-10-31
Completion date
2012-12-31
Last updated
2013-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Diabetes Mellitus, Type 2

Keywords

Resolvment of Diabetes Mellitus, Type 2, gastric bypass

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.

Interventions

PROCEDUREgastric bypass surgery
PROCEDUREabdominal surgery

Sponsors

European Foundation for the Study of Diabetes
CollaboratorOTHER
Medical University of Graz
CollaboratorOTHER
Cantonal Hospital of St. Gallen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> 18 years * indication forbariatric surgery or non-bariatric abdominal surgery

Exclusion criteria

* Pregnancy

Design outcomes

Primary

MeasureTime frame
Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function10 days after gastric bypass

Secondary

MeasureTime frame
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.10 days after gastric bypass
• Plasma concentrations and adipose tissue expression of selected adipokines and inflammatory cytokines characterizing the adipoinsular axis10 days after gastric bypass

Countries

Austria, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026