NCT01049152

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2014

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

4.8 years

First QC Date

January 12, 2010

Last Update Submit

May 21, 2022

Conditions

DiabetesEnd Stage Renal Disease

Keywords

Diabetes mellitusESRDCGMInflammation markersHemodialysisDiabetic patientsNondiabetic patientsAll with ESRDAll undergone hemodialysis

Outcome Measures

Primary Outcomes (1)

  • -Hemodialysis tolerability -Hypoglycemia numbers -Hyperglycemia numbers -Inflammation markers

    before and after each procedure

Secondary Outcomes (1)

  • variations of glycemia during the night; insulin-sensitivity

    at the beginning of the first hemodialysis and at the end of the second hemodialysis

Study Arms (2)

nondiabetic patients

nondiabetic patients with ESRD undergone hemodialysis

Device: Continuous Glucose Monitoring (CGM)

diabetic patients

diabetic patients with ESRD undergone hemodialysis

Device: Continuous Glucose Monitoring (CGM)

Interventions

Continuous Glucose Monitoring (CGM)DEVICE

CGM allocated one time for 3 days

diabetic patientsnondiabetic patients

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • patients with or without diabetes mellitus
  • ESRD
  • undergone hemodialysis
  • males and females aged 50-80

You may not qualify if:

  • tumors
  • chronic inflammation diseases
  • AMI
  • acute pulmonary diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 28110120DERIVED

  • 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.

    PMID: 26387810DERIVED

MeSH Terms

Conditions

Diabetes MellitusKidney Failure, Chronic

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Giuseppe Derosa, MD, PhD

    University of Pavia- Fondazione IRCCS Policlinico San Matteo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 14, 2010

Study Start

July 31, 2009

Primary Completion

May 19, 2014

Study Completion

December 22, 2014

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations

IT(1)