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

NCT ID: NCT01049152

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-12-22

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes End Stage Renal Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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nondiabetic patients

nondiabetic patients with ESRD undergone hemodialysis

Continuous Glucose Monitoring (CGM)

Intervention Type DEVICE

CGM allocated one time for 3 days

diabetic patients

diabetic patients with ESRD undergone hemodialysis

Continuous Glucose Monitoring (CGM)

Intervention Type DEVICE

CGM allocated one time for 3 days

Interventions

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Continuous Glucose Monitoring (CGM)

CGM allocated one time for 3 days

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Derosa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Derosa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia- Fondazione IRCCS Policlinico San Matteo

Locations

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IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

Countries

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Italy

References

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Derosa G, Libetta C, Esposito P, Borettaz I, Tinelli C, D'angelo A, Maffioli P. Effects of two different dialytic treatments on inflammatory markers in people with end-stage renal disease with and without type 2 diabetes mellitus. Cytokine. 2017 Apr;92:75-79. doi: 10.1016/j.cyto.2016.12.026. Epub 2017 Jan 18.

Reference Type DERIVED
PMID: 28110120 (View on PubMed)

Derosa G, Libetta C, Esposito P, Borettaz I, Tinelli C, D'Angelo A, Maffioli P. Bicarbonate dialysis compared to hemodiafiltration on glycemic excursions in patients with end-stage renal disease with and without type 2 diabetes mellitus. J Diabetes Complications. 2015 Nov-Dec;29(8):1136-41. doi: 10.1016/j.jdiacomp.2015.08.009. Epub 2015 Aug 13.

Reference Type DERIVED
PMID: 26387810 (View on PubMed)

Other Identifiers

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20090003173

Identifier Type: -

Identifier Source: org_study_id

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