Clinical trial NCT02413567: Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes
Official title: Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus
Lead sponsor: Fractyl Health Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
timeFrame: 24 weeks post-procedure
measure: Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
timeFrame: 24 weeks post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Leuven
country: Belgium
facility: UZ Leuven
city: Santiago
country: Chile
facility: Centro Clinico de Obesidad
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
state: Lazio
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
References:
citation: van Baar ACG, Deviere J, Hopkins D, Crenier L, Holleman F, Galvao Neto MP, Becerra P, Vignolo P, Rodriguez Grunert L, Mingrone G, Costamagna G, Nieuwdorp M, Guidone C, Haidry RJ, Hayee B, Magee C, Carlos Lopez-Talavera J, White K, Bhambhani V, Cozzi E, Rajagopalan H, J G H M Bergman J. Durable metabolic improvements 2 years after duodenal mucosal resurfacing (DMR) in patients with type 2 diabetes (REVITA-1 Study). Diabetes Res Clin Pract. 2022 Feb;184:109194. doi: 10.1016/j.diabres.2022.109194. Epub 2022 Jan 13.
citation: van Baar ACG, Holleman F, Crenier L, Haidry R, Magee C, Hopkins D, Rodriguez Grunert L, Galvao Neto M, Vignolo P, Hayee B, Mertens A, Bisschops R, Tijssen J, Nieuwdorp M, Guidone C, Costamagna G, Deviere J, Bergman JJGHM. Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes mellitus: one year results from the first international, open-label, prospective, multicentre study. Gut. 2020 Feb;69(2):295-303. doi: 10.1136/gutjnl-2019-318349. Epub 2019 Jul 22.