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Clinical Trials/NCT00456352
NCT00456352CompletedPhase 4

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

Medtronic - MITG2 sites in 1 country37 target enrollmentStarted: April 1, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
37
Locations
2
Primary Endpoint
Treatment success based on patients' glycemic control.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Evaluation of duodenal exclusion procedure for the treatment of T2DM

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age between 20 and 65 years
  • •BMI between 23 and 34
  • •Oral agents or insulin to control T2DM
  • •Inadequate control of diabetes as defined as HbA1c >/ 7.5
  • •Understanding of the mechanisms of action of the treatment

Exclusion Criteria

  • •More than 10 years of T2DM diagnosis
  • •More than 7 years of insulin use
  • •Previous abdominal operations
  • •Coagulopathy
  • •Liver cirrhosis
  • •Unable to comply with study requirements, follow-up schedule or give valid consent.
  • •Currently pregnant.

Outcomes

Primary Outcomes

Treatment success based on patients' glycemic control.

Time Frame: 2 weeks, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes

  • Physiologic measurements, Comorbidity improvement, Improvement in QOL.(2 weeks, 3 months, 6 months, 9 months, 12 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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Duodenal Exclusion for the Treatment of... | Clinical Trial