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临床试验/DRKS00004550
DRKS00004550进行中(未招募)未知

DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m² - Diasurg 2

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universität Heidelberg0 个研究点目标入组 20 人开始时间: 2012年12月20日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
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
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
30 Years 至 70 Years(—)
性别
All

入选标准

  • Diagnosis of T2DM with insulin therapy for at least 3 months; Proof of at least one microvascular manifestation of diabetes (e.g., nephropathy, retinopathy, neuropathy);
  • Residual pancreatic function, which is the premise for autogenic glycaemic control assessed by stimulated fasting C-peptide laboratory tests with a minimum of 1.5 ng/ml; HbA1c at least 7%; ASA at least 3; BMI 26–35 kg/m²; Age 30–70 years;; beta cell autoantibody test for patients who recieved insulin therapy in the past year for diabetes mellitus type II; written informed consent; OK from board-certified endocrinologist

排除标准

  • Type I diabetes mellitus or latent autoimmune Diabetes in adults (LADA); T2DM on diet and/or oral medication; Heart failure (NYHA III–IV); instable angina pectoris; liver cirrhosis; glucocorticoid or other immunosuppressive therapy; puituitary disease/ M. Addison; renal failure (GFR < 45 ml/min); Pregnancy; malignant disease in the past 5 years (except basalioma); history of major abdominal operation; expected lack of compliance; participation in another interventional study with interference of intervention and outcome; inability to give consent

研究者

发起方
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universität Heidelberg

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