Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03130244
• Other study ID #: GIW 16-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: March 30, 2025

Study information

• Verified date: December 2023
• Source: GI Windows, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

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.

Drug:
• Best Medical Management
The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.

Locations

Country	Name	City	State
Argentina	Aleman Hospital	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
GI Windows, Inc.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in HbA1c	The primary effectiveness endpoint is Mean change in HbA1c from baseline	12 months
Secondary	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
Secondary	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
Secondary	Mean change in diabetes medication	Change in diabetes medication requirements from baseline to 12 months	12 months