Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 57

Inclusion Criteria

Participants Age > 28 years and ≤ 75 years
Male or Female
Participants with Type 2 Diabetes who are treated for ≤ 10 years and are on stable oral diabetic medications for a minimum of 3 months
Participants with an HbA1c > 7.5 and ≤ 10.0%
Participants with a BMI > 24 and < 40
Participants willing to comply with study requirements and able to understand and comply with informed consent
Participants who have signed an informed consent form

Exclusion Criteria

Participants diagnosed with Type I Diabetes or with a history of ketoacidosis
Participants using insulin for more than 12 months
Participants with probable insulin production failure (defined as fasting C Peptide serum <1ng/mL)
Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test
Participants requiring prescription anticoagulation therapy and/or dual anti-platelet therapy including aspirin who cannot discontinue their medication for 14 days before and 14 days after the procedure
Participants with iron deficiency anemia - either currently or in their history
Participants with current symptomatic hypocalcemia or vitamin D deficiency (routine calcium and/or vitamin D supplementation would not be excluded)
Participants with or a history of abnormalities of the GI tract preventing endoscopic access to the duodenum,
Participants with symptomatic gallstones or kidney stones at the time of screening
Participants with a history of pancreatitis
Participants with an active systemic infection
Participants with or a history of coagulopathy, upper gastro-intestinal bleeding c conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
Participants with celiac disease
Participants with active malignancy. Those who have had remedial treatment and/or are cancer free for 5 years can be enrolled
Participants with known active hepatitis or active liver disease
Participants emotionally unstable or who exhibit psychological characteristics which, in the opinion of the Investigator, make the participant a poor candidate for clinical trial participation
Participants with previous GI surgery that could affect the ability to treat the duodenum such as participants who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
Participants unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 2 weeks post procedure phase
Participants receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
Participant with a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
Participants with active and uncontrolled gastroesophageal reflux disease (GERD) defined as grade II esophagitis or greater
Participants with active illicit substance abuse or alcoholism
Participants participating in another ongoing investigational clinical trial
Participants taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
Participants who are not potential candidates for duodenal exclusion surgery or general anesthesia

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duodenal Treatment	Fractyl Duodenal Remodeling System	The Duodenal Remodeling procedure utilizes both a trans-oral over the wire and endoscopic approach to minimally invasively ablating and remodeling the duodenum.

Primary Outcome Measures

Name	Time	Method
Changed in Mixed Meal Tolerance From Baseline to 3 Months	3 months	Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months

Secondary Outcome Measures