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OpenTrials
Completed

NCT Number: NCT00456352

Duodenal Exclusion for the Treatment of T2DM

Evaluation of duodenal exclusion procedure for the treatment of T2DM

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital São Camilo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

duodenal exclusion

Procedure

Primary outcomes

  1. Treatment success based on patients' glycemic control.

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

Secondary outcomes

  1. Physiologic measurements, Comorbidity improvement, Improvement in QOL.

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

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Apr 4, 2007
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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