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Mechanisms Behind Antidiabetic Effects by Gastric By-pass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01708096
First Posted: October 16, 2012
Last Update Posted: March 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Uppsala University Hospital
Information provided by (Responsible Party):
Anders Thorell, Karolinska Institutet
  Purpose
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.

Condition Intervention
Diabetes Mellitus Typ 2 and Obesity Dietary Supplement: Modifast Dietary Supplement: Normal diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Mechanisms Behind Antidiabetic Effects by Gastric By-pass

Further study details as provided by Anders Thorell, Karolinska Institutet:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 12-18 month after gastric bypass ]
    Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique


Secondary Outcome Measures:
  • Weight reduction [ Time Frame: 12-18 month after gastric bypass ]

Other Outcome Measures:
  • Insulin signaling and glucose transport in skeletal muscle [ Time Frame: 12-18 month after gastric by-pass ]

Enrollment: 15
Study Start Date: October 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01708096


Locations
Sweden
Karolinska Institutet
Stockholm, Stockholm County Council, Sweden, 116 91
Uppsala University Hospital
Uppsala, Sweden
Sponsors and Collaborators
Karolinska Institutet
Uppsala University Hospital
Investigators
Principal Investigator: Anders Thorell, Assoc Prof Karolinska Institutet
  More Information

Responsible Party: Anders Thorell, Assoc. Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01708096     History of Changes
Other Study ID Numbers: 2009/931-31/2
First Submitted: October 9, 2012
First Posted: October 16, 2012
Last Update Posted: March 12, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs