Mechanisms Behind Antidiabetic Effects by Gastric By-pass

March 11, 2014 updated by: Anders Thorell, Karolinska Institutet
The aim of the study is to develop new strategies in treatment of continuous increasing number of patients with type 2 diabetes by understanding how bariatric surgery cures or improves this condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Uppsala University Hospital
    • Stockholm County Council
      • Stockholm, Stockholm County Council, Sweden, 116 91
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes typ 2
  • 18-70 years
  • BMI > 35 kg/m2
  • Treated with oral antidiabetic agents and/or insulin
  • laparoscopic surgery

Exclusion Criteria:

  • Pharmacological treatment (other then above) witch could affect glucose metabolism
  • open surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Modifast
treated with VLD Modifast 1000 kcal/day in 2 weeks before gastric by-pass,
Dietary supplement: Modifast
2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day
PLACEBO_COMPARATOR: Normal diet
normal diet 2 weeks before gastric by-pass surgery
Dietary supplement: Normal diet
normal diet 2 weeks before gastric by-pass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: 12-18 month after gastric bypass
Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique
12-18 month after gastric bypass

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight reduction
Time Frame: 12-18 month after gastric bypass
12-18 month after gastric bypass

Other Outcome Measures

Outcome Measure
Time Frame
Insulin signaling and glucose transport in skeletal muscle
Time Frame: 12-18 month after gastric by-pass
12-18 month after gastric by-pass

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Uppsala University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (ESTIMATE)

October 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2014

Last Update Submitted That Met QC Criteria

March 11, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2009/931-31/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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