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Mechanisms Behind Antidiabetic Effects by Gastric By-pass

This study has been completed.
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by (Responsible Party):
Anders Thorell, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01708096
First received: October 9, 2012
Last updated: March 11, 2014
Last verified: March 2014

October 9, 2012
March 11, 2014
October 2009
November 2013   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: 12-18 month after gastric bypass ] [ Designated as safety issue: No ]
Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique
Insulin sensitivity [ Time Frame: 12-18 month after gastric bypass ] [ Designated as safety issue: No ]
Insulin sensivity measured by hyperinsulinemic normoglykemic clamp technique
Complete list of historical versions of study NCT01708096 on ClinicalTrials.gov Archive Site
Weight reduction [ Time Frame: 12-18 month after gastric bypass ] [ Designated as safety issue: No ]
Same as current
Insulin signaling and glucose transport in skeletal muscle [ Time Frame: 12-18 month after gastric by-pass ] [ Designated as safety issue: No ]
Insulin signaling and glucose transport in sceletal muscle [ Time Frame: 12-18 month after gastric by-pass ] [ Designated as safety issue: No ]
 
Mechanisms Behind Antidiabetic Effects by Gastric By-pass
Mechanisms Behind Antidiabetic Effects by Gastric By-pass

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Diabetes Mellitus Typ 2 and Obesity
  • Dietary Supplement: Modifast
    2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day
  • Dietary Supplement: Normal diet
    normal diet 2 weeks before gastric by-pass
  • Active Comparator: Modifast
    treated with VLD Modifast 1000 kcal/day in 2 weeks before gastric by-pass,
    Intervention: Dietary Supplement: Modifast
  • Placebo Comparator: Normal diet
    normal diet 2 weeks before gastric by-pass surgery
    Intervention: Dietary Supplement: Normal diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01708096
2009/931-31/2
No
Anders Thorell, Karolinska Institutet
Karolinska Institutet
Uppsala University Hospital
Principal Investigator: Anders Thorell, Assoc Prof Karolinska Institutet
Karolinska Institutet
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP