Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

NCT03130244 | Active Not Recruiting DMC

• 1 other identifier: GIW 16-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Mean change in HbA1c

  The primary effectiveness endpoint is Mean change in HbA1c from baseline

  12 months

Secondary Outcomes (3)

• Mean change in Weight

  12 months

• Proportion of subjects achieving remission

  12 months

• Mean change in diabetes medication

  12 months

Study Arms (2)

Device Placement

ACTIVE COMPARATOR

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

Device: Magnet Anastomosis System; Drug: Best Medical Management

Control

NO INTERVENTION

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

Interventions

Magnet Anastomosis System 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.

Also known as: MAS

Device Placement

Best Medical Management DRUG

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

Also known as: No other intervention

Device Placement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) 30 to 50.
• Subject Type 2 Diabetes Criteria:
• T2DM diagnosis ≥6 months but \< 10 years
• On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose)
• 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)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GI Windows, Inc.: lead

Study Sites (1)

Aleman Hospital

Buenos Aires, Buenos Aires, C1118AAT, Argentina

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rudolf H Buxhoeveden

  Bariatric Surgeon at Hospital Aleman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 26, 2017
• Study Start: September 23, 2019
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)