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A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics | Clinical Trials | Clareo Health

COMPLETED

A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics

NCT00973960•Morphic Medical Inc.

View on ClinicalTrials.gov

Summary

The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes. The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age \> 18 years and \< 55 years - Male or Female
•BMI \> 30 BMI \<60
•Subjects with an HbA1c \> 7.5 and ≤ 10.0%
•Subjects with Type 2 diabetes who have been treated for ≤10 years
•Subjects on Metformin and/or Sulfonylurea
•History of failure with nonsurgical weight loss methods
•Subjects willing to comply with trial requirements
•Subjects who have signed an informed consent form
•Women who are post-menopausal, surgically sterile or on oral contraceptives and who do not plan on becoming pregnant during the course of the trial.

Exclusion Criteria

•Treatment represents an unreasonable risk to the subject
•Subjects on oral diabetic medications other than Metformin or Sulfonylurea
•Subjects on insulin
•Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
•Subjects with a past medical history of hypoglycemia
•Subjects with abnormal gastric emptying at baseline, defined as \< 90% stomach emptied at 4 hours
•Subjects with a weight loss of \> 4.5 Kg (10 lbs) within the 12 Weeks of screening
•Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
•Pregnant or have intention of becoming pregnant for the duration of the trial
•Unresolved alcohol or drug addiction
+18 more criteria

Locations (1)

Hospital Universidad Catolica

Santiago, Chile

Key Dates

Start Date

September 1, 2009

Primary Completion Date

June 1, 2010

Completion Date

December 1, 2010

Last Updated

August 8, 2011

Enrollment

ESTIMATED participants

Conditions

Type 2 Diabetes

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

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