evaluation of duodenal mucosal resurfacing in subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus

Summary: the purpose of this study is to evaluate the fractyl duodenal mucosal resurfacing (dmr) procedure for the treatment of type 2 diabetes.


Eligibility criteria:
inclusion criteria 1. 28 -75 years of age 2. diagnosed with type 2 diabetes for less than 10 years 3. hba1c of 7.5 - 10.0% (59-86 mmol/mol) 4. body mass index (bmi) ≥ 24 and ≤ 40 kg/m2 5. on a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry 6. willing to comply with study requirements and able to understand and comply with informed consent 7. sign an informed consent form exclusion criteria 1. diagnosed with type 1 diabetes or with a history of ketoacidosis 2. probable insulin production failure, defined as fasting c peptide serum \<1ng/ml (333pmol/l) 3. current use of insulin 4. use of glucagon like peptide (glp)-1 analogues 5. hypoglycemia unawareness or a history of severe hypoglycemia (at least 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year) 6. known autoimmune disease, as evidenced by a positive anti glutamic acid decarboxylase (gad) test, including celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder 7. previous gastrointestinal (gi) surgery that could affect the ability to treat the duodenum such as subjects who have had a bilroth 2, roux-en-y gastric bypass, or other similar procedures or conditions 8. history of chronic or acute pancreatitis 9. known active hepatitis or active liver disease 10. symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including crohn's disease and celiac disease 11. history of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia 12. use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure 13. use of p2y12 inhibitors (clopidrogel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. use of aspirin is allowed. 14. unable to discontinue nsaids (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase 15. taking corticosteroids or drugs known to affect gi motility (e.g. metoclopramide) 16. receiving weight loss medications such as meridia, xenical, or over the counter weight loss medications 17. persistent anemia, defined as hgb \< 10 mg/dl 18. estimated glomerular filtration rate (egfr) or modification of diet in renal disease (mdrd) \<30 ml/min/1,73m\^2 19. active systemic infection 20. active malignancy within the last 5 years 21. not potential candidates for surgery or general anesthesia 22. active illicit substance abuse or alcoholism 23. those who are pregnant, nursing or expect to become pregnant over the course of the study 24. participating in another ongoing clinical trial 25. any other mental or physical condition which, in the opinion of the investigator, makes the subject a poor candidate for clinical trial participation