Type 1 DiabetesPROFILNCT01171248
Study of 24 Hour Blood Pressure and the Association to Complications to Type 1 Diabetes
An observational study of Type 1 Diabetes and Hypertension, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP) in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation between central and peripheral 24 hour BP and a possible association to late complications in diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Hypertension
- How many people
- 650 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Aug 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: type 1 diabetic patients (600 patients) non-diabetic controls (50)
Who may be able to join
- Type 1 diabetes
- more than 18 years of age
Who cannot join
- End Stage Renal Disease (ESRD)
- dialysis
- other kidney disease than diabetic nephropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central and Peripheral 24h BP and the Association to Autonomic Neuropathy and Diabetic Nephropathy in Type 1 Diabetic Patients
The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP) in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation between central and peripheral 24 hour BP and a possible association to late complications in diabetes.
- Conditions
- Type 1 Diabetes, Hypertension
- Keywords
- nocturnal blood pressure dip, complications, ambulatory blood pressure
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes | Not described | |
| non-diabetics | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure (AMBP)
The participants are seen once (cross-sectional) and we measure AMBP in order for us to investigate any association between AMBP and other parameters such as age, duration of diabetes, albuminuria status and other diabetic complications.
Measured: 2 years
Secondary outcomes (1)
Diabetic late complications
The participants are only seen once and are at this visit, asked in regards to complications, and the electronic patient medical record is rewieved in regards to complications.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Rossing, Steno Diabetes Center Copenhagen
- Investigators
- Peter Rossing, MD, DmSc, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171248
- Sponsor's protocol ID
- PROFIL-H-B-2009-056
- Acronym
- PROFIL
- Status last verified
- Sep 2011
- First submitted
- 27 Jul 2010
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hansen CS, Rasmussen DGK, Hansen TW, Nielsen SH, Theilade S, Karsdal MA, Genovese F, Rossing P. Collagen turnover is associated with cardiovascular autonomic and peripheral neuropathy in type 1 diabetes: novel pathophysiological mechanism? Cardiovasc Diabetol. 2023 Jun 29;22(1):158. doi: 10.1186/s12933-023-01891-8.
PubMed 37386485Theilade S, Lajer M, Hansen TW, Rossing P. Pulse wave reflection is associated with diabetes duration, albuminuria and cardiovascular disease in type 1 diabetes. Acta Diabetol. 2014 Dec;51(6):973-80. doi: 10.1007/s00592-014-0651-6. Epub 2014 Oct 2.
PubMed 25274394Theilade S, Lajer M, Hansen TW, Joergensen C, Persson F, Andresdottir G, Reinhard H, Nielsen SE, Lacy P, Williams B, Rossing P. 24-hour central aortic systolic pressure and 24-hour central pulse pressure are related to diabetic complications in type 1 diabetes - a cross-sectional study. Cardiovasc Diabetol. 2013 Aug 27;12:122. doi: 10.1186/1475-2840-12-122.
PubMed 23978271
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral 24h BP and the Association to Autonomic Neuropathy and Diabetic Nephropathy in Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01171248
- Acronym / sponsor ID
- PROFIL / PROFIL-H-B-2009-056
- Conditions
- Type 1 Diabetes, Hypertension
- Keywords
- nocturnal blood pressure dip, complications, ambulatory blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 28 Jul 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.
The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP) in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation between central and peripheral 24 hour BP and a possible association to late complications in diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes | – | – |
| non-diabetics | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- type 1 diabetic patients (600 patients) non-diabetic controls (50)
Key inclusion criteria (2 listed)
- Type 1 diabetes
- more than 18 years of age
Key exclusion criteria (3 listed)
- End Stage Renal Disease (ESRD)
- dialysis
- other kidney disease than diabetic nephropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ambulatory blood pressure (AMBP)
Time frame: 2 years
The participants are seen once (cross-sectional) and we measure AMBP in order for us to investigate any association between AMBP and other parameters such as age, duration of diabetes, albuminuria status and other diabetic complications.
1 secondary outcome
Diabetic late complications
Time frame: 2 years
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 22 Sep 2011.
- Derived from this study: PubMed 37386485Hansen CS, Rasmussen DGK, Hansen TW, Nielsen SH, Theilade S, Karsdal MA, Genovese F, Rossing P. Collagen turnover is associated with cardiovascular autonomic and peripheral neuropathy in type 1 diabetes: novel pathophysiological mechanism? Cardiovasc Diabetol. 2023 Jun 29;22(1):158. doi: 10.1186/s12933-023-01891-8.
- Derived from this study: PubMed 25274394Theilade S, Lajer M, Hansen TW, Rossing P. Pulse wave reflection is associated with diabetes duration, albuminuria and cardiovascular disease in type 1 diabetes. Acta Diabetol. 2014 Dec;51(6):973-80. doi: 10.1007/s00592-014-0651-6. Epub 2014 Oct 2.
- Derived from this study: PubMed 23978271Theilade S, Lajer M, Hansen TW, Joergensen C, Persson F, Andresdottir G, Reinhard H, Nielsen SE, Lacy P, Williams B, Rossing P. 24-hour central aortic systolic pressure and 24-hour central pulse pressure are related to diabetic complications in type 1 diabetes - a cross-sectional study. Cardiovasc Diabetol. 2013 Aug 27;12:122. doi: 10.1186/1475-2840-12-122.
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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.
Peter Rossing, MD, DmSc principal investigator
Steno Diabetes Center Copenhagen
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 Type 1 Diabetes and Hypertension, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 3 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 22 Sep 2011. 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 Denmark. 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?
Ambulatory blood pressure (AMBP) (time frame: 2 years). 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 NCT01171248, which also lists 3 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 22 Sep 2011.