Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus

Obesity Clinical Trial

Official title:

A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04627103
• Other study ID #: GIW 20-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: October 31, 2024

Study information

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

Clinical Trial Summary

Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.

Description:

Multi-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: October 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 19-65 years at screening
• Body mass index (BMI) =35 and =50
• T2DM diagnosis =6 months but < 10 years, with 1 or more oral diabetes medications, HbA1c = 6.5% but < 10.0% at time of enrollment.
• HbA1c must be stable over a 3-month period.
• Weight stable over 3-month period
• Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled
• Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years
• If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period
• Able to understand and sign informed consent documents.

Exclusion Criteria:

• Known or suspected allergy to nickel or titanium or nitinol
• Type 1 diabetes or poorly controlled type 2 diabetes
• Use of injectable insulin
• Any documented conditions for which endoscopy would be contraindicated
• Contraindication to general anesthesia
• History of chronic gastrointestinal disease
• Congenial or acquired anomalies of the GI tract
• Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
• Uncontrolled hypertension
• Pre-existing severe comorbid cardio-respiratory disease
• History of chronic gastrointestinal disease
• Specific genetic or hormonal cause of obesity
• Recent tobacco/nicotine product cessation (within 3 months prior)

Related Conditions & MeSH terms

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

Intervention

Device:
• Self Forming Magnetic (SFM) Anastomosis System
The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact Type 2 Diabetes. Following the diversion being created, a gastric sleeve will be created according to standard technique.

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Université Laval	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
GI Windows, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	Weight loss measured as a percent of total body weight (TBW)	12 months
Secondary	Percent Responders	Percent responders; i.e. percent of subjects losing at least 10% TBW	12 months
Secondary	Excess Weight Loss Measures	Excess weight loss (EWL)	12 months
Secondary	Absolute Weight Loss Measures	Absolute weight loss	12 months
Secondary	BMI - Weight Loss Measures	Change in BMI	12 months
Secondary	Fasting Glucose	Mean change in fasting glucose	12 months
Secondary	Hemoglobin A1c	Mean change in Hemoglobin A1c	12 months
Secondary	Diabetes Remission and/or Improvements	Proportion of subjects experiencing diabetes remission and/or improvements	12 months
Secondary	Diabetes Medication Dosage and Frequency Changes	Mean change in the dosage and frequency of diabetes medications from baseline	12 months
Secondary	Serum Lipids	Mean change in serum lipids	12 months
Secondary	Blood Pressure Changes	Mean percent change in systolic/diastolic blood pressure	12 months
Secondary	Liver Changes using Fibroscan	Change in Controlled Attenuation Parameter (CAP) Scores from baseline	12 months
Secondary	Nutritional Status	Nutritional Status: changes in pre-albumin levels	12 months
Secondary	Albumin - Nutritional Status	Nutritional Status: changes in albumin levels	12 months