Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

• Sponsor: GI Windows, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03130244
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 62.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Obesity	Device: Magnet Anastomosis System; Drug: Best Medical Management	N/A

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
• Anticipated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Trial for a Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
• Actual Study Start Date: Sep 23, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Device Placement The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created.	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.; Other Names: MAS ; Drug: Best Medical Management; The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.; Other Names: No other intervention
No Intervention: Control The patients in this arm will receive the best medical management.

Outcome Measures

Primary Outcome Measures

1. Mean change in HbA1c [12 months]

   The primary effectiveness endpoint is Mean change in HbA1c from baseline

Secondary Outcome Measures

1. Mean change in Weight [12 months]

   12 month weight loss measured as a percent of total body weight loss and excess weight loss (using the BMI method) as well as weight/BMI change from baseline

2. Proportion of subjects achieving remission [12 months]

   Proportion of subjects experiencing diabetes remission and/or partial remission at 12 months (as defined by the American Diabetes Association)

3. Mean change in diabetes medication [12 months]

   Change in diabetes medication requirements from baseline to 12 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aleman Hospital	Buenos Aires		Argentina	C1118AAT

Sponsors and Collaborators

• GI Windows, Inc.

Investigators

• Principal Investigator: Rudolf H Buxhoeveden, Bariatric Surgeon at Hospital Aleman

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GI Windows, Inc.
• ClinicalTrials.gov Identifier: NCT03130244
• Other Study ID Numbers: GIW 16-001
• First Posted: Apr 26, 2017
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 13, 2021