Diabetes Mellitus, Type 2NCT04499638
Incidence of Complications of Peripheral Venous Access in the Type 2 Diabetic Population
An observational study of Diabetes Mellitus, Type 2 and Catheterization, Peripheral, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Diabetes Mellitus type 2 (T2DM) is one of the most frequent metabolic diseases worldwide. It is expected that in 2035 around 600 million people will suffer from the disease. A recent systematic review has estimated that the direct annual cost of Diabetes worldwide treatments and care is over $ 827 billion and has been… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Catheterization, Peripheral, Upper Extremity Deep Vein Thrombosis
- What is being tested?
- Peripheral vascular catheters
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 15 May 2021
- How long will I take part?
- 1 Year
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to our hospital who require intravenous treatment and a peripheral venous device has been placed
Who may be able to join
- Peripheral venous access requirement >7 days
- Administration of intravenous treatment
Who cannot join
- Peripheral venous access for urgent or life-threatening pathology
- Acute psychiatric pathology
- Impossibility of peripheral venous access through the upper limb (amputations, extensive burns, etc.)
- History of venous thrombosis due to catheter less than 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Complications of Peripheral Venous Access in the Type 2 Diabetic Population. Analysis of Risk Factors and Comparative Study of Two Peripheral Devices
Diabetes Mellitus type 2 (T2DM) is one of the most frequent metabolic diseases worldwide. It is expected that in 2035 around 600 million people will suffer from the disease. A recent systematic review has estimated that the direct annual cost of Diabetes worldwide treatments and care is over $ 827 billion and has been independently associated with nosocomial complications, thrombosis-like infections and prolonged admissions. In addition, it is estimated that up to 90% of patients in acute hospitals require a peripheral venous catheter which are associated at the same time with mechanical, infectious and thrombotic acute complications. Recently the emergence of new medium-sized peripheral devices (Midline®) and new peripheral central venous access catheters (PICC), which are more biocompatible, are opening new clinical possibilities with the aim of improving safety and comfort during treatment time and the reduction of associated complications.
With all this, an observational case-control study has been proposed in order to analyse the impact of T2DM disease and its associated complications on the patient requiring peripheral venous access. Furthermore investigators will consider if these new peripheral devices can be a remarkable benefit for these patients. This study will be carried out at the Vall d'Hebron University Hospital in Barcelona, Spain
Read the detailed description
This Prospective case-control study will be carried out with patients that will be admitted in the hospitalization areas of the Vall d'Hebron Hospital. All research data will be collected by the hospital's vascular access nursing team. Complications related to peripheral venous access (phlebitis, thrombosis, pain, erythema, extravasation) and the time of catheter replacement are the focus outcomes of the present study and possible differences between the control group and the sample population of the T2DM will be analysed. General clinical and anthropometric data (age, sex, BMI, toxic habits,...), cause of admission, co-morbidities, and all variables related to diabetes (time of evolution, degree of glycemic control, treatment, and presence of chronic complications) will also be collected. If there are any significant differences, they will be related to the different risk factors associated with T2DM through association of different epidemiological variables. Furthermore in this hypothetical case, the research team would intend to develop and carry out molecular studies through analysis of blood and urine components, proteinomics and genetic studies.
Hypothesis:
- T2DM is an independent risk factor for catheter-related complications.
- The use of new vascular access devices (Midline, PICC) in patients with T2DM would be associated with a lower risk of catheter-related complications.
Main objective:
- To assess the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients.
It is expected to colect information of N=500 samples, 250 control group (noT2DM subjects) and 250 study group (T2DM subjects). Due to previous experience, the sample proposed is totally acceptable
- Conditions
- Diabetes Mellitus, Type 2, Catheterization, Peripheral, Upper Extremity Deep Vein Thrombosis, Catheter-Related Infections, Diabetes Complications
- Being tested
- Peripheral vascular catheters
- Keywords
- Diabetes Mellitus Type 2, Catheter-Related complications, Short peripheral venous catheter, Medium line peripheral catheter (Midline), Peripheral Insertion Central Catheter (PICC)
- Medical subject headings
- Diabetes Mellitus, Type 2, Upper Extremity Deep Vein Thrombosis, Catheter-Related Infections, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral vascular cathetersDevice
Also called Short canula, Midline, PICC
Carry time of common peripheral vascular devices in clinical practice and the reason for his withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Non type 2 diabetic patient | Tracking the catheter from insertion to removal. Collection of any patients complication associated with these devices and what different treatments has been administered Receives: Device: Peripheral vascular catheters | |
| Diabetic type 2 patient | Tracking the catheter from insertion to removal.Collection of any patients complication associated with these devices and what different treatments has been administered Receives: Device: Peripheral vascular catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
How is the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients
Rate of complications associated with catheters: thrombosis, infection, pain and skin reaction
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jan 2020
- Primary completion30 Jan 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 350 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Simó, Prof., Study director, Vall Hebron Research Institute-VHIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499638
- Sponsor's protocol ID
- PR(AG)74/2020
- Status last verified
- Feb 2025
- First submitted
- 31 Jul 2020
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nowotny K, Jung T, Hohn A, Weber D, Grune T. Advanced glycation end products and oxidative stress in type 2 diabetes mellitus. Biomolecules. 2015 Mar 16;5(1):194-222. doi: 10.3390/biom5010194.
PubMed 25786107Asmat U, Abad K, Ismail K. Diabetes mellitus and oxidative stress-A concise review. Saudi Pharm J. 2016 Sep;24(5):547-553. doi: 10.1016/j.jsps.2015.03.013. Epub 2015 Mar 21.
PubMed 27752226Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
PubMed 11333990American Diabetes Association. Standards of Medical Care in Diabetes-2017 Abridged for Primary Care Providers. Clin Diabetes. 2017 Jan;35(1):5-26. doi: 10.2337/cd16-0067. No abstract available.
PubMed 28144042Tangvarasittichai S. Oxidative stress, insulin resistance, dyslipidemia and type 2 diabetes mellitus. World J Diabetes. 2015 Apr 15;6(3):456-80. doi: 10.4239/wjd.v6.i3.456.
PubMed 25897356Hurrle S, Hsu WH. The etiology of oxidative stress in insulin resistance. Biomed J. 2017 Oct;40(5):257-262. doi: 10.1016/j.bj.2017.06.007. Epub 2017 Nov 8.
PubMed 29179880Banerjee M, Vats P. Reactive metabolites and antioxidant gene polymorphisms in Type 2 diabetes mellitus. Redox Biol. 2014;2:170-7. doi: 10.1016/j.redox.2013.12.001. Epub 2013 Dec 11.
PubMed 25460725Ley SH, Ardisson Korat AV, Sun Q, Tobias DK, Zhang C, Qi L, Willett WC, Manson JE, Hu FB. Contribution of the Nurses' Health Studies to Uncovering Risk Factors for Type 2 Diabetes: Diet, Lifestyle, Biomarkers, and Genetics. Am J Public Health. 2016 Sep;106(9):1624-30. doi: 10.2105/AJPH.2016.303314. Epub 2016 Jul 26.
PubMed 27459454Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, Del Canizo-Gomez FJ. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J Diabetes. 2014 Aug 15;5(4):444-70. doi: 10.4239/wjd.v5.i4.444.
PubMed 25126392Lowe G, Woodward M, Hillis G, Rumley A, Li Q, Harrap S, Marre M, Hamet P, Patel A, Poulter N, Chalmers J. Circulating inflammatory markers and the risk of vascular complications and mortality in people with type 2 diabetes and cardiovascular disease or risk factors: the ADVANCE study. Diabetes. 2014 Mar;63(3):1115-23. doi: 10.2337/db12-1625. Epub 2013 Nov 12.
PubMed 24222348Seuring T, Archangelidi O, Suhrcke M. The Economic Costs of Type 2 Diabetes: A Global Systematic Review. Pharmacoeconomics. 2015 Aug;33(8):811-31. doi: 10.1007/s40273-015-0268-9.
PubMed 25787932Sayampanathan AA. Systematic review of complications and outcomes of diabetic patients with burn trauma. Burns. 2016 Dec;42(8):1644-1651. doi: 10.1016/j.burns.2016.06.023. Epub 2016 Aug 29.
PubMed 27595452Low ZK, Ng WY, Fook-Chong S, Tan BK, Chong SJ, Hwee J, Tay SM. Comparison of clinical outcomes in diabetic and non-diabetic burns patients in a national burns referral center in Southeast Asia: A 3-year retrospective review; Methodological issues. Burns. 2017 Sep;43(6):1368. doi: 10.1016/j.burns.2017.03.019. Epub 2017 Jun 9. No abstract available.
PubMed 28602590Vondran M, Schack S, Garbade J, Binner C, Mende M, Rastan AJ, Borger MA, Schroeter T. Evaluation of risk factors for a fulminant Clostridium difficile infection after cardiac surgery: a single-center, retrospective cohort study. BMC Anesthesiol. 2018 Sep 27;18(1):133. doi: 10.1186/s12871-018-0597-2.
PubMed 30257648Keogh S, Marsh N, Higgins N, Davies K, Rickard C. A time and motion study of peripheral venous catheter flushing practice using manually prepared and prefilled flush syringes. J Infus Nurs. 2014 Mar-Apr;37(2):96-101. doi: 10.1097/NAN.0000000000000024.
PubMed 24583939
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Complications of Peripheral Venous Access in the Type 2 Diabetic Population. Analysis of Risk Factors and Comparative Study of Two Peripheral Devices
- ClinicalTrials.gov ID
- NCT04499638
- Acronym / sponsor ID
- PR(AG)74/2020
- Conditions
- Diabetes Mellitus, Type 2, Catheterization, Peripheral, Upper Extremity Deep Vein Thrombosis, Catheter-Related Infections, Diabetes Complications
- Keywords
- Diabetes Mellitus Type 2, Catheter-Related complications, Short peripheral venous catheter, Medium line peripheral catheter (Midline), Peripheral Insertion Central Catheter (PICC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 5 Aug 2020 (actual)
- 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.
Diabetes Mellitus type 2 (T2DM) is one of the most frequent metabolic diseases worldwide. It is expected that in 2035 around 600 million people will suffer from the disease. A recent systematic review has estimated that the direct annual cost of Diabetes worldwide treatments and care is over $ 827 billion and has been independently associated with nosocomial complications, thrombosis-like infections and prolonged admissions. In addition, it is estimated that up to 90% of patients in acute hospitals require a peripheral venous catheter which are associated at the same time with mechanical, infectious and thrombotic acute complications. Recently the emergence of new medium-sized peripheral devices (Midline®) and new peripheral central venous access catheters (PICC), which are more biocompatible, are opening new clinical possibilities with the aim of improving safety and comfort during treatment time and the reduction of associated complications.
With all this, an observational case-control study has been proposed in order to analyse the impact of T2DM disease and its associated complications on the patient requiring peripheral venous access. Furthermore investigators will consider if these new peripheral devices can be a remarkable benefit for these patients. This study will be carried out at the Vall d'Hebron University Hospital in Barcelona, Spain
Detailed description
This Prospective case-control study will be carried out with patients that will be admitted in the hospitalization areas of the Vall d'Hebron Hospital. All research data will be collected by the hospital's vascular access nursing team. Complications related to peripheral venous access (phlebitis, thrombosis, pain, erythema, extravasation) and the time of catheter replacement are the focus outcomes of the present study and possible differences between the control group and the sample population of the T2DM will be analysed. General clinical and anthropometric data (age, sex, BMI, toxic habits,...), cause of admission, co-morbidities, and all variables related to diabetes (time of evolution, degree of glycemic control, treatment, and presence of chronic complications) will also be collected. If there are any significant differences, they will be related to the different risk factors associated with T2DM through association of different epidemiological variables. Furthermore in this hypothetical case, the research team would intend to develop and carry out molecular studies through analysis of blood and urine components, proteinomics and genetic studies.
Hypothesis:
- T2DM is an independent risk factor for catheter-related complications.
- The use of new vascular access devices (Midline, PICC) in patients with T2DM would be associated with a lower risk of catheter-related complications.
Main objective:
- To assess the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients.
It is expected to colect information of N=500 samples, 250 control group (noT2DM subjects) and 250 study group (T2DM subjects). Due to previous experience, the sample proposed is totally acceptable
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non type 2 diabetic patient | – | Device: Peripheral vascular cathetersTracking the catheter from insertion to removal. Collection of any patients complication associated with these devices and what different treatments has been administered |
| Diabetic type 2 patient | – | Device: Peripheral vascular cathetersTracking the catheter from insertion to removal.Collection of any patients complication associated with these devices and what different treatments has been administered |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to our hospital who require intravenous treatment and a peripheral venous device has been placed
Key inclusion criteria (2 listed)
- Peripheral venous access requirement >7 days
- Administration of intravenous treatment
Key exclusion criteria (4 listed)
- Peripheral venous access for urgent or life-threatening pathology
- Acute psychiatric pathology
- Impossibility of peripheral venous access through the upper limb (amputations, extensive burns, etc.)
- History of venous thrombosis due to catheter less than 1 year
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 |
|---|---|---|
| Peripheral vascular cathetersAlso: Short canula, Midline, PICCCarry time of common peripheral vascular devices in clinical practice and the reason for his withdrawal | Device | Diabetic type 2 patient, Non type 2 diabetic patient |
Primary outcome
How is the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients
Time frame: 12 month
Rate of complications associated with catheters: thrombosis, infection, pain and skin reaction
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 25 Feb 2025.
- Background: PubMed 25786107Nowotny K, Jung T, Hohn A, Weber D, Grune T. Advanced glycation end products and oxidative stress in type 2 diabetes mellitus. Biomolecules. 2015 Mar 16;5(1):194-222. doi: 10.3390/biom5010194.
- Background: PubMed 27752226Asmat U, Abad K, Ismail K. Diabetes mellitus and oxidative stress-A concise review. Saudi Pharm J. 2016 Sep;24(5):547-553. doi: 10.1016/j.jsps.2015.03.013. Epub 2015 Mar 21.
- Background: PubMed 11333990Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
- Background: PubMed 28144042American Diabetes Association. Standards of Medical Care in Diabetes-2017 Abridged for Primary Care Providers. Clin Diabetes. 2017 Jan;35(1):5-26. doi: 10.2337/cd16-0067. No abstract available.
- Background: PubMed 25897356Tangvarasittichai S. Oxidative stress, insulin resistance, dyslipidemia and type 2 diabetes mellitus. World J Diabetes. 2015 Apr 15;6(3):456-80. doi: 10.4239/wjd.v6.i3.456.
- Background: PubMed 29179880Hurrle S, Hsu WH. The etiology of oxidative stress in insulin resistance. Biomed J. 2017 Oct;40(5):257-262. doi: 10.1016/j.bj.2017.06.007. Epub 2017 Nov 8.
- Background: PubMed 25460725Banerjee M, Vats P. Reactive metabolites and antioxidant gene polymorphisms in Type 2 diabetes mellitus. Redox Biol. 2014;2:170-7. doi: 10.1016/j.redox.2013.12.001. Epub 2013 Dec 11.
- Background: PubMed 27459454Ley SH, Ardisson Korat AV, Sun Q, Tobias DK, Zhang C, Qi L, Willett WC, Manson JE, Hu FB. Contribution of the Nurses' Health Studies to Uncovering Risk Factors for Type 2 Diabetes: Diet, Lifestyle, Biomarkers, and Genetics. Am J Public Health. 2016 Sep;106(9):1624-30. doi: 10.2105/AJPH.2016.303314. Epub 2016 Jul 26.
- Background: PubMed 25126392Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, Del Canizo-Gomez FJ. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J Diabetes. 2014 Aug 15;5(4):444-70. doi: 10.4239/wjd.v5.i4.444.
- Background: PubMed 24222348Lowe G, Woodward M, Hillis G, Rumley A, Li Q, Harrap S, Marre M, Hamet P, Patel A, Poulter N, Chalmers J. Circulating inflammatory markers and the risk of vascular complications and mortality in people with type 2 diabetes and cardiovascular disease or risk factors: the ADVANCE study. Diabetes. 2014 Mar;63(3):1115-23. doi: 10.2337/db12-1625. Epub 2013 Nov 12.
- Background: PubMed 25787932Seuring T, Archangelidi O, Suhrcke M. The Economic Costs of Type 2 Diabetes: A Global Systematic Review. Pharmacoeconomics. 2015 Aug;33(8):811-31. doi: 10.1007/s40273-015-0268-9.
- Background: PubMed 27595452Sayampanathan AA. Systematic review of complications and outcomes of diabetic patients with burn trauma. Burns. 2016 Dec;42(8):1644-1651. doi: 10.1016/j.burns.2016.06.023. Epub 2016 Aug 29.
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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.
Rafael Simó, Prof. study director
Vall Hebron Research Institute-VHIR
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 Mellitus, Type 2 and Catheterization, Peripheral, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 2 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 25 Feb 2025. 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 Spain. 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?
How is the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients (time frame: 12 month). 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 NCT04499638, which also lists 22 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 25 Feb 2025.