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
  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
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:


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 sensitivity measured by hyperinsulinemic normoglycemic 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 skeletal muscle [ Time Frame: 12-18 month after gastric by-pass ] [ Designated as safety issue: No ]

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

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 insulin
  • laparoscopic surgery

Exclusion Criteria:

  • Pharmacological treatment (other then above) witch could affect glucose metabolism
  • open surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: March 11, 2014
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 August 26, 2014