NL-OMON44146已完成不适用
Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes - REVITA-1
Fractyl Laboratories, Inc.0 个研究点目标入组 11 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •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
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