Duodenal Exclusion for the Treatment of T2DM

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00456352

Enrollment

Registered

2007-04-04

Start date

2007-04-30

Completion date

2010-10-31

Last updated

2014-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

Evaluation of duodenal exclusion procedure for the treatment of T2DM

Interventions

PROCEDUREduodenal exclusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

1. Age between 20 and 65 years 2. BMI between 23 and 34 3. Oral agents or insulin to control T2DM 4. Inadequate control of diabetes as defined as HbA1c \>/ 7.5 5. Understanding of the mechanisms of action of the treatment

Exclusion criteria

1. More than 10 years of T2DM diagnosis 2. More than 7 years of insulin use 3. Previous abdominal operations 4. Coagulopathy 5. Liver cirrhosis 6. Unable to comply with study requirements, follow-up schedule or give valid consent. 7. Currently pregnant.

Design outcomes

Primary

Measure	Time frame
Treatment success based on patients' glycemic control.	2 weeks, 3 months, 6 months, 9 months, 12 months

Secondary

Measure	Time frame
Physiologic measurements, Comorbidity improvement, Improvement in QOL.	2 weeks, 3 months, 6 months, 9 months, 12 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026