Duodenal Exclusion for the Treatment of Type 2 Diabetes

Diabetes Clinical Trial

Official title:

Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes (T2DM)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00534547
• Other study ID #: AS07009
• Status: Withdrawn
• Phase: N/A
• First received: September 24, 2007
• Last updated: July 23, 2015

Study information

• Verified date: July 2015
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Procedure:
• Duodenal Exclusion
duodenal-jejunal bypass

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success based on patients' glycemic control		12 Months	No
Secondary	Physiologic Measurements, Comorbidity improvement, Improvement in QOL		12 Months	No