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Mechanisms Behind Antidiabetic Effects by Gastric By-pass

This study is currently recruiting participants.
Verified October 2012 by Karolinska Institutet
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: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

The aim of the study is to develop new strategies in treatment of continous 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Mechanisms Behind Antidiabetic Effects by Gastric By-pass

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 12-18 month after gastric bypass ] [ Designated as safety issue: No ]
    Insulin sensivity measured by hyperinsulinemic normoglykemic clamp technique


Secondary Outcome Measures:
  • Weight reduction [ Time Frame: 12-18 month after gastric bypass ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Insulin signaling and glucose transport in sceletal muscle [ Time Frame: 12-18 month after gastric by-pass ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pharmacological treatment (other then above) witch could affect glucose metabolism
  • open surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708096

Contacts
Contact: Anders Thorell, Assoc prof +46 (0) 8 7146541 ext 6451 anders.thorell@erstadiakoni.se

Locations
Sweden
Karolinska Institutet Recruiting
Stockholm, Stockholm County Council, Sweden, 116 91
Contact: Anders Thorell, Ass.prof.     +46 87146000 ext 6541     anders.thorell@erstadiakoni.se    
Uppsala University Hospital Active, not recruiting
Uppsala, Sweden
Sponsors and Collaborators
Karolinska Institutet
Uppsala University Hospital
Investigators
Principal Investigator: Anders Thorell, Assoc Prof Karolinska Institutet
  More Information

No publications provided

Responsible Party: Anders Thorell, Assoc. Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01708096     History of Changes
Other Study ID Numbers: 2009/931-31/2
Study First Received: October 9, 2012
Last Updated: October 15, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013