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Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

A Trial for a Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

NCT03130244•GI Windows, Inc.

View on ClinicalTrials.gov

Summary

Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.

Detailed Description

Randomized, Single-Center, Parallel-group, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Magnet Anastomosis System (MAS) When Used to Create a Dual-path Enteral Diversion Compared with Medical Therapy Alone To Effect Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus (T2DM)

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Body mass index (BMI) 30 to 50.
•Subject Type 2 Diabetes Criteria:
•1. T2DM diagnosis ≥6 months but \< 10 years
•2. On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose)
•3. Hemoglobin A1C (HbA1c) between and including 6.5 and 10.0% (58 mmol/mol to 86 mmol/mol) at time of enrollment and has had a stable HbA1c over a 3-month period (i.e., \<0.3% reduction)
•4. Stable medication regimen (i.e., no change in diabetes medications) for at least 3 months prior to Screening Visit.
•If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
•Able to understand and sign informed consent document
•Has primary care physician and/or endocrinologist who follows patient for all comorbid conditions

Exclusion Criteria

•Known or suspected allergy to nickel or titanium or Nitinol
•Type 1 Diabetes
•Use of injectable insulin
•Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L)
•Probable insulin production failure, defined as fasting serum C Peptide \<1 ng/mL (0.3 nmol/l)
•Any documented conditions for which endoscopy/colonoscopy would be contraindicated.
•Contraindication to general anesthesia
•Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation.
•Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas or right colon.
•Previous technically difficult or failed colonoscopy or endoscopy
+6 more criteria

Locations (1)

Aleman Hospital

Buenos Aires, Buenos Aires, Argentina

Key Dates

Start Date

September 23, 2019

Primary Completion Date

December 30, 2025

Completion Date

December 30, 2025

Last Updated

June 26, 2025

Enrollment

ACTUAL participants

Conditions

Type 2 DiabetesObesity

Interventions

Magnet Anastomosis System

DEVICE

Best Medical Management

DRUG

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

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RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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: June 26, 2025Data 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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Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

Feasibility of a Tailored Online Self-compassion Intervention

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