Clinical trial NCT03130244: Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
Official title: A Trial for a Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Lead sponsor: GI Windows, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)

Eligibility 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)

Primary outcomes:
measure: Mean change in HbA1c
timeFrame: 12 months
Secondary outcomes:
measure: Mean change in Weight
timeFrame: 12 months
measure: Proportion of subjects achieving remission
timeFrame: 12 months
measure: Mean change in diabetes medication
timeFrame: 12 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Aleman Hospital
Study officials:
affiliation: Bariatric Surgeon at Hospital Aleman
name: Rudolf H Buxhoeveden
role: PRINCIPAL_INVESTIGATOR
References: