Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GI Windows, Inc.

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)