Type2 Diabetes MellitusPRECISEDNCT02248311
"Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population
An observational study of Type2 Diabetes Mellitus and Microangiopathy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Current methods based on traditional Cardiovascular risk factors are not clinically useful for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic events (ie.myocardial infarction or stroke). Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes Mellitus, Microangiopathy, Non Alcoholic Fatty Liver Disease
- How many people
- 260 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Oct 2018
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 200 T2D diabetic patients without history of clinical Cardiovascular disease will be recruited from the Outpatient Diabetic Clinic of Vall d'Hebron Hospital and the Primary Health Care centers under its influence area. Sixty non-diabetic patients without classic Cardiovascular risk factors matched by age will be used as a control group. Specifically, vascular risk factors, concomitant diseases, family history of Cardiovascular disease or stroke and the treatments taken at the time of inclusion will be collected.
Who may be able to join
- a) Age from 50-79 years; b) History of type 2diabetes of at least one year. Diabetes will be defined following the American Diabetic Association criteria: fasting glucose level of at least 126 mg/dl [7.0 mmol/l] in two separate analyses, a non-fasting glucose level of at least 200 mg/dl [11.1 mmol/l] or a self-reported history of physician-diagnosed diabetes or treatment for diabetes
Who cannot join
- a) Past medical history of Cardiovascular event; b) Type 1 diabetes; c) Contraindication for PET-CT or MRI d) Other concomitant disease associated with a short life expectancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population: a Multidisciplinary Clinical and Experimental Approach" (PRECISED)
Current methods based on traditional Cardiovascular risk factors are not clinically useful for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in Type 2 Diabetes population have worse prognosis than in general population. In fact, there is sufficient experimental evidence indicating that diabetes exaggerates the deleterious effects of ischemic events and worsens their outcome.
A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2 Diabetes patients. Therefore, new strategies aimed at identifying those patients with this subclinical Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular events is a challenge to be met.
Read the detailed description
Objectives
- To examine whether the extension and degree of microangiopathy is an independent risk factor for silent myocardial and brain ischemia. 2) To evaluate whether the degree and extension of microangiopathy is a predictor of CV events and poor outcome. 3) To evaluate whether a new score based on the extension and the degree of microangiopathy will permit us to improve the current methods used to identify patients at risk of CVD and its outcomes. 4) To determine whether the presence and the degree of NAFLD is an independent Cardiovascular disease risk factor and represent and extra-value to the score based on the extension and the degree of microangiopathy.
Secondary objectives:
- To examine the usefulness of selected serum biomarkers in identifying diabetic patients at risk of Cardiovascular disease 2) To evaluate whether these selected biomarkers are related to the degree and extension of microangiopathy and the outcome of cardiovascular events. 3) To better define the meaning of microalbuminuria in type 2 diabetic population (glomerular involvement vs. index of generalized endothelial dysfunction)
- Conditions
- Type2 Diabetes Mellitus, Microangiopathy, Non Alcoholic Fatty Liver Disease, Coronary Artery Disease, Cerebrovascular Disease, Acute Coronary Syndrome/ Myocardial Infarction
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Coronary Artery Disease, Cerebrovascular Disorders
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 |
|---|---|---|
| Patients/Control Group | Observational | |
| Patients/Group Control | Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subclinical Cardiovascular Diseases
Number of Type 2 Diabetes (T2D) patients presenting subclinical Cardiovascular disease as defined by the presence of brain infarcts (MRI), myocardial infarcts, or myocardial ischemia or > 50% coronary artery stenosis (PET-SPECT)
Measured: 1 week
Secondary outcomes (1)
Ischemic events
- Occurrence of Cardiovascular events during the 3 year follow up: Ictus, transient ischemic attack, acute coronary syndrome (STEMI or NSTEMI), angina, sudden cardiac death.
- Incidence of major adverse cardiovascular events at 30 days following acute ischemic syndrome (Death, Re-infarction, Ictus)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies 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
- 260 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David García-Dorado Garcia, PhD MD, Principal investigator, Hospital Universitario Valle de Hebron, Barcelona, SpainJoan Montaner Vilallonga, PhD MD, Principal investigator, Hospital Universitario Valle de Hebron, Barcelona, SpainRafael Simó Canonge, PhD MD, Principal investigator, Hospital Universitario Valle de Hebron, Barcelona, SpainJoan Sayós Ortega, PhD MD, Principal investigator, Hospital Universitario Valle de Hebron, Barcelona, SpainDaniel Serón Micas, PhD MD, Principal investigator, Hospital Universitario Valle de Hebron, Barcelona, SpainJoan Genescà Ferrer, PhD MD, Principal investigator, Hospital Universitario Valle de Hebron, Barcelona, SpainSantiago Aguadé Bruix, PhD MD, Principal investigator, Hospital Universitario Valle de Hebron, Barcelona, SpainJoan Xavier Comella Carnicé, PhD MD, Principal investigator, Hospital Universitario Valle de Hebron, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248311
- Sponsor's protocol ID
- PRECISED ISCiii-PIE-13
- Acronym
- PRECISED
- Status last verified
- Jan 2018
- First submitted
- 18 Sep 2014
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population: a Multidisciplinary Clinical and Experimental Approach" (PRECISED)
- ClinicalTrials.gov ID
- NCT02248311
- Acronym / sponsor ID
- PRECISED / PRECISED ISCiii-PIE-13
- Conditions
- Type2 Diabetes Mellitus, Microangiopathy, Non Alcoholic Fatty Liver Disease, Coronary Artery Disease, Cerebrovascular Disease, Acute Coronary Syndrome/ Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 25 Sep 2014 (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.
Current methods based on traditional Cardiovascular risk factors are not clinically useful for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in Type 2 Diabetes population have worse prognosis than in general population. In fact, there is sufficient experimental evidence indicating that diabetes exaggerates the deleterious effects of ischemic events and worsens their outcome.
A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2 Diabetes patients. Therefore, new strategies aimed at identifying those patients with this subclinical Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular events is a challenge to be met.
Detailed description
Objectives
- To examine whether the extension and degree of microangiopathy is an independent risk factor for silent myocardial and brain ischemia. 2) To evaluate whether the degree and extension of microangiopathy is a predictor of CV events and poor outcome. 3) To evaluate whether a new score based on the extension and the degree of microangiopathy will permit us to improve the current methods used to identify patients at risk of CVD and its outcomes. 4) To determine whether the presence and the degree of NAFLD is an independent Cardiovascular disease risk factor and represent and extra-value to the score based on the extension and the degree of microangiopathy.
Secondary objectives:
- To examine the usefulness of selected serum biomarkers in identifying diabetic patients at risk of Cardiovascular disease 2) To evaluate whether these selected biomarkers are related to the degree and extension of microangiopathy and the outcome of cardiovascular events. 3) To better define the meaning of microalbuminuria in type 2 diabetic population (glomerular involvement vs. index of generalized endothelial dysfunction)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients/Control Group | – | –Observational |
| Patients/Group Control | – | –Observational |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 200 T2D diabetic patients without history of clinical Cardiovascular disease will be recruited from the Outpatient Diabetic Clinic of Vall d'Hebron Hospital and the Primary Health Care centers under its influence area. Sixty non-diabetic patients without classic Cardiovascular risk factors matched by age will be used as a control group. Specifically, vascular risk factors, concomitant diseases, family history of Cardiovascular disease or stroke and the treatments taken at the time of inclusion will be collected.
Key inclusion criteria (1 listed)
- a) Age from 50-79 years; b) History of type 2diabetes of at least one year. Diabetes will be defined following the American Diabetic Association criteria: fasting glucose level of at least 126 mg/dl [7.0 mmol/l] in two separate analyses, a non-fasting glucose level of at least 200 mg/dl [11.1 mmol/l] or a self-reported history of physician-diagnosed diabetes or treatment for diabetes
Key exclusion criteria (1 listed)
- a) Past medical history of Cardiovascular event; b) Type 1 diabetes; c) Contraindication for PET-CT or MRI d) Other concomitant disease associated with a short life expectancy
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
Subclinical Cardiovascular Diseases
Time frame: 1 week
Number of Type 2 Diabetes (T2D) patients presenting subclinical Cardiovascular disease as defined by the presence of brain infarcts (MRI), myocardial infarcts, or myocardial ischemia or > 50% coronary artery stenosis (PET-SPECT)
1 secondary outcome
Ischemic events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Related trials for Type2 Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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.
David García-Dorado Garcia, PhD MD principal investigator
Hospital Universitario Valle de Hebron, Barcelona, Spain
Joan Montaner Vilallonga, PhD MD principal investigator
Hospital Universitario Valle de Hebron, Barcelona, Spain
Rafael Simó Canonge, PhD MD principal investigator
Hospital Universitario Valle de Hebron, Barcelona, Spain
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 Type2 Diabetes Mellitus and Microangiopathy, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jan 2018. 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?
Results are not available in the source record.
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?
Subclinical Cardiovascular Diseases (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2018.