Continuous Glucose Monitoring and Inflammation in Nondiab... | NCT01049152

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

NCT01049152

Sponsor

University of Pavia

Status

Completed

Last Update Posted

May 24, 2022Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Diabetes
End Stage Renal Disease

Interventions

Continuous Glucose Monitoring (CGM)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2009Actual

Primary Completion Date

May 19, 2014Actual

Completion Date

Dec 22, 2014Actual

First Submitted Date

Jan 12, 2010

First Submission Date that Met QC Criteria

Jan 13, 2010

First Posted Date

Jan 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2022

Last Update Posted Date

May 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Continuous Glucose Monitoring (CGM)	Device	CGM allocated one time for 3 days	diabetic patients nondiabetic patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giuseppe Derosa, MD, PhD	University of Pavia- Fondazione IRCCS Policlinico San Matteo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Policlinico San Matteo		Pavia		27100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28110120	Derived	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.
26387810	Derived

ID	Term
D003920	Diabetes Mellitus
D007676	Kidney Failure, Chronic

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures