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

May 21, 2022 updated by: Giuseppe Derosa, University of Pavia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

outpatients will undergo CGM at two different hemodialysis methods in a croos-over design. At the end of the study, it will evaluate inflammation markers intra-and inter-groups during the different hemodialysis methods.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
nondiabetic patients
nondiabetic patients with ESRD undergone hemodialysis
Device: Continuous Glucose Monitoring (CGM)
CGM allocated one time for 3 days
diabetic patients
diabetic patients with ESRD undergone hemodialysis
Device: Continuous Glucose Monitoring (CGM)
CGM allocated one time for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
-Hemodialysis tolerability -Hypoglycemia numbers -Hyperglycemia numbers -Inflammation markers
Time Frame: before and after each procedure
before and after each procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
variations of glycemia during the night; insulin-sensitivity
Time Frame: at the beginning of the first hemodialysis and at the end of the second hemodialysis
at the beginning of the first hemodialysis and at the end of the second hemodialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

  • Principal Investigator: Giuseppe Derosa, MD, PhD, University of Pavia- Fondazione IRCCS Policlinico San Matteo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2009

Primary Completion (Actual)

May 19, 2014

Study Completion (Actual)

December 22, 2014

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 21, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20090003173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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