Clinical trial NCT04627103: Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
Official title: A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Type 2 Diabetes Mellitus
Keywords: Obesity
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Disease
Sleeve Gastrectomy
Lead sponsor: GI Windows, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-13
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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)

Eligibility criteria: 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)

Primary outcomes:
measure: Weight Loss
timeFrame: 12 months
Secondary outcomes:
measure: Percent Responders
timeFrame: 12 months
measure: Excess Weight Loss Measures
timeFrame: 12 months
measure: Absolute Weight Loss Measures
timeFrame: 12 months
measure: BMI - Weight Loss Measures
timeFrame: 12 months
measure: Fasting Glucose
timeFrame: 12 months
measure: Hemoglobin A1c
timeFrame: 12 months
measure: Diabetes Remission and/or Improvements
timeFrame: 12 months
measure: Diabetes Medication Dosage and Frequency Changes
timeFrame: 12 months
measure: Serum Lipids
timeFrame: 12 months
measure: Blood Pressure Changes
timeFrame: 12 months
measure: Liver Changes using Fibroscan
timeFrame: 12 months
measure: Nutritional Status
timeFrame: 12 months
measure: Albumin - Nutritional Status
timeFrame: 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Quebec City
country: Canada
facility: Université Laval
state: Quebec
Study officials:
References: