Back to resultsProcedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
Primary Purpose
Type 2 Diabetes, Obesity
Status
Active
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Magnet Anastomosis System
Best Medical Management
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
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)
Sites / Locations
- Aleman Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Device Placement
Control
Arm Description
The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created.
The patients in this arm will receive the best medical management.
Outcomes
Primary Outcome Measures
Mean change in HbA1c
The primary effectiveness endpoint is Mean change in HbA1c from baseline
Secondary Outcome Measures
Mean change in Weight
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
Proportion of subjects achieving remission
Proportion of subjects experiencing diabetes remission and/or partial remission at 12 months (as defined by the American Diabetes Association)
Mean change in diabetes medication
Change in diabetes medication requirements from baseline to 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03130244
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GI Windows, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device Placement
Arm Type
Active Comparator
Arm Description
The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients in this arm will receive the best medical management.
Intervention Type
Device
Intervention Name(s)
Magnet Anastomosis System
Other Intervention Name(s)
MAS
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Best Medical Management
Other Intervention Name(s)
No other intervention
Intervention Description
The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.
Primary Outcome Measure Information:
Title
Mean change in HbA1c
Description
The primary effectiveness endpoint is Mean change in HbA1c from baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean change in Weight
Description
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
Time Frame
12 months
Title
Proportion of subjects achieving remission
Description
Proportion of subjects experiencing diabetes remission and/or partial remission at 12 months (as defined by the American Diabetes Association)
Time Frame
12 months
Title
Mean change in diabetes medication
Description
Change in diabetes medication requirements from baseline to 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf H Buxhoeveden
Organizational Affiliation
Bariatric Surgeon at Hospital Aleman
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aleman Hospital
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
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