NCT03130244Active, not recruitingNot Applicable
A Trial for a Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
GI Windows, Inc.1 site in 1 country15 target enrollmentStarted: September 23, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Mean change in HbA1c
Study Overview
Brief Summary
Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Body mass index (BMI) 30 to
- •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
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)
Arms & Interventions
Device Placement
Active Comparator
The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created.
Intervention: Magnet Anastomosis System (Device)
Device Placement
Active Comparator
The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created.
Intervention: Best Medical Management (Drug)
Control
No Intervention
The patients in this arm will receive the best medical management.
Outcomes
Primary Outcomes
Mean change in HbA1c
Time Frame: 12 months
The primary effectiveness endpoint is Mean change in HbA1c from baseline
Secondary Outcomes
- Mean change in Weight(12 months)
- Proportion of subjects achieving remission(12 months)
- Mean change in diabetes medication(12 months)
Investigators
Study Sites (1)
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