NL-OMON48696已完成不适用
Evaluation of the effect of Duodenal Mucosal Resurfacing (DMR) using the Revita System in the treatment of Type 2 diabetes (T2D) - Revita-2 Study
Fractyl Laboratories Inc.0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- •1. 28-75 years of age
- •2. Diagnosed with Type 2 Diabetes and evidence of preserved insulin secretion.
- •Fasting insulin > 7.0 µU/ mL.
- •3. HbA1c of 7.5 - 10.0% (59-86 mmol/mol)
- •4. Body Mass Index (BMI) >= 24 and <= 40 kg/m2
- •5. Currently taking one or more oral glucose lowering medications, of which one
- •must be Metformin, with no changes in dose or medication in the previous 12
- •Weeks prior to study entry.
- •6. Able to comply with study requirements and understand and sign the informed
排除标准
- •1. Diagnosed with Type 1 Diabetes or with a history of
- •ketoacidosis
- •2. Current use of Insulin
- •3. Current use of GLP-1 analogues
- •4. 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)
- •5. 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
- •6. Active H. pylori infection (Participants with active H. pylori may
- •continue with the screening process if they are treated via
- •medication.)
- •7. Previous GI surgery that could affect the ability to treat the
- •duodenum such as subjects who have had a Bilroth 2, Rouxen-
- •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 (clopidogrel, 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 antiinflammatory
- •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 g/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. Participating in another ongoing clinical trial of an
- •investigational drug or device
- •24. Any other mental or physical condition which, in the opinion of
- •the Investigator, makes the subject a poor candidate for
- •clinical trial participation
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