Duodenal exclusion for the treatment of type 2 diabetes mellitus

Not Applicable

Completed

• Conditions: Type Two Diabetes Mellitus (T2DM); Nutritional, Metabolic, Endocrine; Diabetes Mellitus

• Registration Number: ISRCTN79580044
• Lead Sponsor: S Surgical (USA)

Brief Summary

2012 results in https://www.ncbi.nlm.nih.gov/pubmed/22410638 (added 07/02/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-22
• Study Completion: 2008-10-11
• Last Update Posted: 4 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age between 20 and 65 years old
2. Body Mass Index (BMI) between 23 and 34
3. Oral agents or insulin to control Type Two Diabetes Mellitus (T2DM)
4. Inadequate control of diabetes as defined as HbA1c greater than 7.5 mg/dl
5. Understanding of the mechanisms of action of the treatment

Exclusion Criteria

1. More than ten years of T2DM diagnosis
2. More than seven years of insulin use
3. Previous abdominal operations
4. Coagulopathy
5. Liver cirrhosis
6. Unable to comply with study requirements, follow-up schedule or give valid informed consent
7. Currently pregnant (pregnancy test required for confirmation for those of child bearing years)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment success, evaluated at 6 and 12 months, based on patients? glycaemic control measured by achieving HbA1c level less than 7% as per the ADA recommendation.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Improvement in physiological measurements (glycaemic control, lipids) (success determined at 6 and 12 months)<br> 2. Co-morbidity improvement, determined by comparing pre-operative co-morbidities to the status post-operatively (success determined at 12 months)<br> 3. Improvement in Quality of Life using the 36-item Short Form (SF-36) questionnaire, determined by comparing pre-operative to post-operative quality of life (success determined at 12 months). We have licensed the SF-36 questionnaire from Quality Metrics and will utilise their guide for interpreting the data<br>