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临床试验/NCT01049750
NCT01049750已完成不适用

Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients

University of Pavia1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
1
主要终点
Prevalence of erectile dysfunction

研究概览

简要总结

The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability Score)questionnaires.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • type 2 diabetes mellitus

排除标准

  • type 1 diabetes mellitus
  • < 18 years old
  • anatomic abnormalities of the penis
  • patients taking erectile dysfunction therapy at the moment of the enrollment

结局指标

主要结局

Prevalence of erectile dysfunction

时间窗: Baseline (time 0); 3 months; 6 months

Evaluation of diabetic neuropathy in patients with erectile dysfunction

时间窗: Baseline (time 0); 3 months; 6 months

Description of erectile disfunction markers

时间窗: Baseline (time 0); 3 months; 6 months

次要结局

  • Metalloproteinases 2 and 9(Baseline (time 0); 3 months; 6 months)
  • Insulin-sensitivity index (HOMA index)(Baseline (time 0); 3 months; 6 months)
  • Glycemic control(Baseline (time 0); 3 months; 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Derosa

Professor

University of Pavia

研究点 (1)

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