DiabetesNCT01049152
Continuous Glucose Monitoring and Inflammation in Nondiabetic and Diabetic Patients Undergone Hemodialysis
An observational study of Diabetes and End Stage Renal Disease, run by University of Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Diabetes, End Stage Renal Disease
- What is being tested?
- Continuous Glucose Monitoring (CGM)
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2009to 22 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- patients with or without diabetes mellitus
- ESRD
- undergone hemodialysis
- males and females aged 50-80
Who cannot join
- tumors
- chronic inflammation diseases
- AMI
- acute pulmonary diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes, End Stage Renal Disease
- Being tested
- Continuous Glucose Monitoring (CGM)
- Keywords
- Diabetes mellitus, ESRD, CGM, Inflammation markers, Hemodialysis, Diabetic patients, Nondiabetic patients, All with ESRD, All undergone hemodialysis
- Medical subject headings
- Diabetes Mellitus, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring (CGM)Device
CGM allocated one time for 3 days
| Study group | Role | What they receive |
|---|---|---|
| nondiabetic patients | nondiabetic patients with ESRD undergone hemodialysis Receives: Device: Continuous Glucose Monitoring (CGM) | |
| diabetic patients | diabetic patients with ESRD undergone hemodialysis Receives: Device: Continuous Glucose Monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Hemodialysis tolerability -Hypoglycemia numbers -Hyperglycemia numbers -Inflammation markers
Measured: before and after each procedure
Secondary outcomes (1)
variations of glycemia during the night; insulin-sensitivity
Measured: at the beginning of the first hemodialysis and at the end of the second hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study start31 Jul 2009
- Primary completion19 May 2014
- Study completion22 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
- Investigators
- Giuseppe Derosa, MD, PhD, Principal investigator, University of Pavia- Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049152
- Sponsor's protocol ID
- 20090003173
- Status last verified
- May 2022
- First submitted
- 12 Jan 2010
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28110120Derosa 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.
PubMed 26387810
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring and Inflammation in Nondiabetic and Diabetic Patients Undergone Hemodialysis
- ClinicalTrials.gov ID
- NCT01049152
- Acronym / sponsor ID
- 20090003173
- Conditions
- Diabetes, End Stage Renal Disease
- Keywords
- Diabetes mellitus, ESRD, CGM, Inflammation markers, Hemodialysis, Diabetic patients, Nondiabetic patients, All with ESRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 31 Jul 2009 (actual)
- Primary completion
- 19 May 2014 (actual)
- Study completion
- 22 Dec 2014 (actual)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nondiabetic patients | – | Device: Continuous Glucose Monitoring (CGM)nondiabetic patients with ESRD undergone hemodialysis |
| diabetic patients | – | Device: Continuous Glucose Monitoring (CGM)diabetic patients with ESRD undergone hemodialysis |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- patients with or without diabetes mellitus
- ESRD
- undergone hemodialysis
- males and females aged 50-80
Key exclusion criteria (4 listed)
- tumors
- chronic inflammation diseases
- AMI
- acute pulmonary diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitoring (CGM)CGM allocated one time for 3 days | Device | diabetic patients, nondiabetic patients |
Primary outcome
-Hemodialysis tolerability -Hypoglycemia numbers -Hyperglycemia numbers -Inflammation markers
Time frame: before and after each procedure
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 28110120Derosa 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.
- Derived from this study: PubMed 26387810Derosa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Derosa, MD, PhD principal investigator
University of Pavia- Fondazione IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and End Stage Renal Disease, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Hemodialysis tolerability -Hypoglycemia numbers -Hyperglycemia numbers -Inflammation markers (time frame: before and after each procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01049152, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.