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NCT01049152 Clinical Trial

Continuous Glucose Monitoring and Inflammation in Nondiabetic and Diabetic Patients Undergone Hemodialysis

Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01049152
Other study ID # 20090003173
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 31, 2009
Est. completion date December 22, 2014

Study information
Verified date May 2022
Source University of Pavia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluation of different glycemic variations between the dialysis period and non-dialysis period in two groups: nondiabetic and diabetic patients undergone two different hemodialysis methods. Thirty-six patients, males and females, aged 50-80 years, with end stage renal disease (ESRD) will undergo hemodialysis and continuous glucose monitoring (CGM). The investigators will evaluate also inflammation markers before and after the different hemodialysis methods.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date December 22, 2014
Est. primary completion date May 19, 2014
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - patients with or without diabetes mellitus - ESRD - undergone hemodialysis - males and females aged 50-80 Exclusion Criteria: - tumors - chronic inflammation diseases - AMI - acute pulmonary diseases

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Continuous Glucose Monitoring (CGM)
CGM allocated one time for 3 days

Locations
Country Name City State
Italy IRCCS Policlinico San Matteo Pavia

Sponsors (1)
Lead Sponsor Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary -Hemodialysis tolerability -Hypoglycemia numbers -Hyperglycemia numbers -Inflammation markers before and after each procedure
Secondary variations of glycemia during the night; insulin-sensitivity at the beginning of the first hemodialysis and at the end of the second hemodialysis
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