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Mechanisms Behind Antidiabetic Effects by Gastric By-pass

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


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

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
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Please refer to this study by its identifier: NCT01708096

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

Responsible Party: Anders Thorell, Assoc. Professor, Karolinska Institutet Identifier: NCT01708096     History of Changes
Other Study ID Numbers: 2009/931-31/2
Study First Received: October 9, 2012
Last Updated: March 11, 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017