Effect of glicemia normalization in fasting conditions by insulinic intensive treatment on frequency of restenosis after periferic angioplastic in patients affected by diabetes mellitus type II. - ND

Phase 1

• Conditions: diabetes mellitus type II; MedDRA version: 9.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitus

• Registration Number: EUCTR2008-000686-30-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-20
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

-patients of both sex aged between 30 and 75 years old;-female in climateric state;-patients able to give their consent; patients affected by diabetes mellitus type IIFPG >7.0 mmol/l or PPG  11.1 mmol/l or prevous diabetes diagnosis etc.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-diabetes mellitus type I; -positivity forAb antiGAD dosed by RIA method; -rejection of sc teraphy; -acute limb ischemia; -Buerger illness; etc.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to estabilish the role of the fasting mormoglicemia obtained by intensive insulinic treatment for 6 months in:<br>-angiographic stenosis reduction after periferc angioplastic<br>-increase of % of clinical success to FU etc<br><br>-;Secondary Objective: to verify if fasting normoglicemia obtained by intensive insulinic treatment is able to reduce or to avoid planned or not palnned amputations;Primary end point(s): to estabilish the role of the fasting mormoglicemia obtained by intensive insulinic treatment for 6 months in:<br>-angiographic stenosis reduction after periferc angioplastic<br>-increase of % of clinical success to FU etc<br><br>-