Duodenal Exclusion for the Treatment of Type 2 Diabetes

Medtronic - MITG

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Diabetes

Interventions

Duodenal ExclusionPROCEDURE

duodenal-jejunal bypass

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment success based on patients' glycemic control

Time frame: 12 Months

Secondary Outcomes

Physiologic Measurements, Comorbidity improvement, Improvement in QOL

Time frame: 12 Months

Data from ClinicalTrials.gov

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