Resumen

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

Descripción detallada

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)

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Body mass index (BMI) 30 to 50.
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

Criterios de exclusión

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)

Intervenciones

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.

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