Clinical trial
Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03130244
Active, not recruitingNot applicableInterventional
What this study is about
Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes, Obesity
Full registry criteria
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)
Treatments and study arms
Magnet Anastomosis System
Device
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.
Best Medical Management
Drug
The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.
Primary outcomes
Mean change in HbA1c12 months
The primary effectiveness endpoint is Mean change in HbA1c from baseline
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Aleman Hospital🇦🇷 Buenos Aires, Argentina