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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Type 2 Diabetes
• Intervention / Treatment: Device: Magnet Anastomosis System; Drug: Best Medical Management

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)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1118AAT
    • Aleman Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Device Placement; The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created.	Device: 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.; Other Names: MAS; Drug: Best Medical Management; The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.; Other Names: No other intervention
No Intervention: Control; The patients in this arm will receive the best medical management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in HbA1c	The primary effectiveness endpoint is Mean change in HbA1c from baseline	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Weight	12 month weight loss measured as a percent of total body weight loss and excess weight loss (using the BMI method) as well as weight/BMI change from baseline	12 months
Proportion of subjects achieving remission	Proportion of subjects experiencing diabetes remission and/or partial remission at 12 months (as defined by the American Diabetes Association)	12 months
Mean change in diabetes medication	Change in diabetes medication requirements from baseline to 12 months	12 months

Collaborators and Investigators

• Sponsor: GI Windows, Inc.
• Investigators: Principal Investigator: Rudolf H Buxhoeveden, Bariatric Surgeon at Hospital Aleman

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GIW 16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No