Mechanisms Behind Antidiabetic Effects by Gastric By-pass

Not Applicable

Completed

• Conditions: Diabetes Mellitus Typ 2 and Obesity
• Interventions: Dietary Supplement: Modifast; Dietary Supplement: Normal diet

• Registration Number: NCT01708096
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-11
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modifast	Modifast	treated with VLD Modifast 1000 kcal/day in 2 weeks before gastric by-pass,
Normal diet	Normal diet	normal diet 2 weeks before gastric by-pass surgery

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	12-18 month after gastric bypass	Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique

Secondary Outcome Measures

Name	Time	Method
Weight reduction	12-18 month after gastric bypass

Trial Locations

Locations (2)

Karolinska Institutet; 🇸🇪 Stockholm, Stockholm County Council, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden