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Mechanisms Behind Antidiabetic Effects by Gastric By-pass

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ClinicalTrials.gov Identifier: NCT01708096
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : March 12, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Diabetes Mellitus Typ 2 and Obesity Dietary Supplement: Modifast Dietary Supplement: Normal diet

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Mechanisms Behind Antidiabetic Effects by Gastric By-pass
Study Start Date : October 2009
Primary Completion Date : November 2013
Study Completion Date : November 2013
Arms and Interventions

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


Outcome Measures

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


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

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

Eligibility Criteria

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 Posted: October 16, 2012    Key Record Dates
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