Duodenal Exclusion for the Treatment of Type 2 Diabetes

Medtronic

Status: Withdrawn

Conditions: Diabetes

Treatments: Procedure: Duodenal Exclusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534547

AS07009

Details and patient eligibility

About

The purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means.

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 20 and 50 years old;
• BMI between 27 and 34.9;
• Oral agents or insulin to control T2DM;
• Inadequate control of diabetes as defined as HbA1c>8.0% but <10%
• Understanding of the mechanisms of action of the treatment

Exclusion criteria

• More than 5 years of T2DM diagnosis;
• C-peptide <1pg/ml (off insulin)
• Previous abdominal operations;
• History of gastritis
• History of GERD
• History of peptic ulcer disease
• Inflammatory bowel disease
• Coagulopathy;
• Liver cirrhosis;
• Unable to comply with study requirements, follow-up schedule or give valid informed consent;
• Currently pregnant (pregnancy test required for confirmation for those of child bearing years)
• Patient is not available for programmed follow-up during the study period
• Patient is unwilling to forgo good samaritan blood donation during the study period

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)