Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

NCT ID: NCT03130244

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2025-12-30

Brief 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)

Conditions

Type 2 Diabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device Placement

The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created.

Group Type: ACTIVE_COMPARATOR

Magnet Anastomosis System

Intervention Type: DEVICE

The MAS will be placed using an endoscope in the duodenum and and laparoscopically into ileum. A compression anastomosis will be created in each of the patients and the diversion of enteral flow from the duodenum to ileum treats Type 2 diabetes.

Best Medical Management

Intervention Type: DRUG

The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.

Control

The patients in this arm will receive the best medical management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Magnet Anastomosis System

The MAS will be placed using an endoscope in the duodenum and and laparoscopically into ileum. A compression anastomosis will be created in each of the patients and the diversion of enteral flow from the duodenum to ileum treats Type 2 diabetes.

Intervention Type: DEVICE

Best Medical Management

The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.

Intervention Type: DRUG

Other Intervention Names

MAS; No other intervention

Eligibility Criteria

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
• If on metformin, history of polycystic ovarian syndrome (PCOS)
• Unable or unwilling to perform home blood glucose monitoring
• History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease)
• Diagnosis of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin
• Previous surgical or endoscopic treatment for obesity including but not restricted to intragastric balloons, endoscopic suturing or stapling procedures, malabsorptive sleeves.
• Specific genetic or hormonal cause of obesity (e.g. Prader-Willi syndrome)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GI Windows, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rudolf H Buxhoeveden

Role: PRINCIPAL_INVESTIGATOR

Bariatric Surgeon at Hospital Aleman

Locations

Aleman Hospital

Buenos Aires, Buenos Aires, Argentina

Countries

Argentina

Other Identifiers

GIW 16-001

Identifier Type: -

Identifier Source: org_study_id