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Diabetes Mellitus, Type 2NCT01271062

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

A study testing gastric bypass surgery, abdominal surgery and very low caloric diet in people with Diabetes Mellitus, Type 2 and Bariatric Surgery Candidate, run by Cantonal Hospital of St. Gallen at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gastric bypass surgery, abdominal surgery and very low caloric diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesin 2 countries
Study dates
Oct 2009to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Pregnancy

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

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

    Graz, 8036

Other trials in Austria

Switzerland1 site

  • Interdisciplinary Obesity Center, Kantonal Hospital St. Gallen, Switzerland

    Sankt Gallen, 9400

Other trials in Switzerland

About this study

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

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.

Being tested
gastric bypass surgery, abdominal surgery, very low caloric diet
Keywords
Resolvment of Diabetes Mellitus, Type 2, gastric bypass
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gastric bypass surgeryProcedure or surgery

  • abdominal surgeryProcedure or surgery

  • very low caloric dietBehavioural

Study groups in NCT01271062
Study groupRoleWhat they receive
T2DM patients before gastric bypass surgeryActive comparatororal glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.
Receives: Procedure: gastric bypass surgery
Non-diabetic patient before gastric bypass surgeryActive comparatororal glucose tolerance test , botnia clamp, preoperative as well as 10 days postoperative and 1 year postoperative, gastric bypass surgery.
Receives: Procedure: gastric bypass surgery
non diabetic patients, non-bariatric abdominal surgeryActive comparatororal glucose tolerance test , botnia clamp, elective laparoscopic abdominal surgery.
Receives: Procedure: abdominal surgery
severely obese T2DM patients following a very low caloric dietActive comparatororal glucose tolerance test , botnia clamp, before as well after following a very low caloric diet. Very low caloric diet.
Receives: Behavioral: very low caloric diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute insulin response (AIR) to glucose during IVGTT will be used as a primary variable characterizing the beta cell function

    Measured: 10 days after gastric bypass

Secondary outcomes (2)

  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.

    Measured: 10 days after gastric bypass

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

    Measured: 10 days after gastric bypass

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2011 (estimated)
  2. Study startOct 2009
  3. Primary completionNov 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01271062
Sponsor's protocol ID
EKSG 09/061/2B
Status last verified
Mar 2013
First submitted
5 Jan 2011
Last updated
7 Mar 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing gastric bypass surgery, abdominal surgery and very low caloric diet in people with Diabetes Mellitus, Type 2 and Bariatric Surgery Candidate, run by Cantonal Hospital of St. Gallen at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01271062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2013.

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