Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes
- Conditions
- Treatment diabetes10018424
- Registration Number
- NL-OMON44146
- Lead Sponsor
- Fractyl Laboratories, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
Screening Visit (Pre-Medication Run-In, Visit 1)
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. BMI * 24 and * 40 kg/m2
5. On a minimum of 1 stable oral anti-diabetic medication 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
Screening Visit (Pre-Medication Run-In, Visit 1)
1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
2. Probable insulin production failure, defined as fasting C Peptide serum <1 ng/mL (333pmol/l)
3. Current use of Insulin
4. Use of GLP-1 analogues
5. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 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-GAD test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
7. Previous 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. eGFR or 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 investigational 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;Baseline Visit (Post Medication Run-In, Visit 2)
1. HbA1c post run-in phase < 7.5% (59 mmol/mol) or > 10.0% (86 mmol/mol)
2. Hypoglycemic event defined as a plasma glucose level of < 56 mg/dL (3.1 mmol/L) with symptoms, or at least 2 self-monitored finger sticks < 56mg/dL without symptoms or a severe hypoglycemic event, as defined by third-party-assistance, since the screening visit (Visit 1)
3. Hyperglycemic event defined as three self-monitored finger sticks in 1 day during the run-in period with fasting blood glucose measurements >15 mmol/L (270 mg/dL) or non-fasting blood glucose measurements >20 mmol/L (360 mg/dL) or any combination of the two. Fasting glucose hyperglycemia is not an exclusion if measured at the actual baseline visit (Visit 2) blood analysis test.;Procedure (Visit 3)
1. Active and uncontrolled GERD defined as grade III esophagitis or greater
2. Abnormalities of the GI tract preve
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method