Type 2 DiabetesPRE-STARtNCT02545140
Prevention Strategies for Adolescents at Risk of Diabetes
An observational study of Type 2 Diabetes and Chronic Disease, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
The primary aim of PRE-STARt Phase 1 is to pragmatically evaluate and refine a risk assessment tool to identify those children with chronic disease risk factors (including Type 2 Diabetes). Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Chronic Disease
- How many people
- 634 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Dec 2016
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Boys and girls who are between 12 and 14 years of age who do not have an existing diagnosis of type 1 or type 2 diabetes.
Who may be able to join
- Young people aged between 12-14 years of age
- be willing and able to give assent
- have obtained written parent/guardian consent.
Who cannot join
- are outside the age range of interest (i.e. aged less than 12 years or greater than 14 years of age)
- do not have parental consent or do not give assent
- have an existing diagnosis of type 1 or type 2 diabetes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester
Leicester, LE4 5pW
About this study
Official title: Prevention Strategies for Adolescents at Risk of Diabetes - Validation of a Risk Tool for Young People Aged 12 - 14 Years
The primary aim of PRE-STARt Phase 1 is to pragmatically evaluate and refine a risk assessment tool to identify those children with chronic disease risk factors (including Type 2 Diabetes).
Read the detailed description
Data will be collected in 5 European Commission countries (500 adolescents in total). A range of biological and lifestyle measures will be collected in order to investigate the adolescent's lifestyle and will include body weight and other anthropometric measurements, blood pressure, blood capillary sample, self-reported physical activity, sedentary behaviour and dietary habits. Their parent/guardian will complete a number of questions to gather information about variables that have been associated with chronic disease (including type 2 diabetes) and include peri-natal history (birth weight, gestational diabetes), socioeconomic status, family health and medical history.
A draft risk tool to identify those children with a 'higher risk' of developing type 2 diabetes in the future has been developed systematic review results and a Delphi procedure. This draft tool will be evaluated and refined. This draft risk tool will be evaluated by independent clinical reviewers against the data collected from the 500 adolescent data sets. The results for each adolescent will be independently reviewed by clinicians who will assign either a "lower" or "higher" risk to each case. The results will be compared to the results from the draft 'PRE-START tool', used to further refine this identification tool using appropriate statistical methods.
The outputs of this study will be a fit for purpose 'PRE-STARt tool' that can be used for recruitment to interventional studies whose primary objective is to reduce the risk of developing chronic disease (including type 2 diabetes) in the future.
- Conditions
- Type 2 Diabetes, Chronic Disease
- Being tested
- No intervention
- Keywords
- risk factors, screening, adolescents
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| UK (Lead Site) | Data will be collected from 100 adolescents from each participating site providing clinical data for 500 adolescents providing a cross-sectional cohort from each of the following countries:
UK (Lead Site) Germany Portugal Greece Spain (Basque Country) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic disease risk factor - Body mass index (BMI)
Height and weight will be measured to calculated BMI
Measured: 12 months
Secondary outcomes (8)
Chronic disease risk factor - waist circumference
Measured: 12 months
Chronic disease risk factor - blood pressure
Measured: 12 months
Chronic disease risk factor - glycated haemoglobin (HbA1c)
Measured: 12 months
Chronic disease risk factor - high density lipoprotein cholesterol
Measured: 12 months
Chronic disease risk factor - glucose
Fasted and/or unfasted
Measured: 12 months
Chronic disease risk factor - low density lipoprotein cholesterol
Calculated
Measured: 12 months
Chronic disease risk factor - triglycerides
Measured: 12 months
Chronic disease risk factor - total cholesterol
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, Associacao Protectora dos Diabeticos de Portugal, The Algarve Regional Health Administration, University of Leipzig, Technische Universität Dresden, Alexander Technological Educational Institute, Thessaloniki, Greece, Diabetes Centre of Paediatrics P&A, Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Primary Care Centre Egia, San Sebastian, Spain, Basque Government Department of Public Health, Health Department of the Alto/Bajo Deba
- Responsible party
- Sponsor
- Investigators
- Melanie J Davies, MD, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545140
- Sponsor's protocol ID
- 173431
- Acronym
- PRE-STARt
- Status last verified
- Jan 2019
- First submitted
- 7 Sep 2015
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Strategies for Adolescents at Risk of Diabetes - Validation of a Risk Tool for Young People Aged 12 - 14 Years
- ClinicalTrials.gov ID
- NCT02545140
- Acronym / sponsor ID
- PRE-STARt / 173431
- Conditions
- Type 2 Diabetes, Chronic Disease
- Keywords
- risk factors, screening, adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- University of Leicester, Associacao Protectora dos Diabeticos de Portugal, The Algarve Regional Health Administration, University of Leipzig, Technische Universität Dresden, Alexander Technological Educational Institute, Thessaloniki, Greece, Diabetes Centre of Paediatrics P&A, Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Primary Care Centre Egia, San Sebastian, Spain, Basque Government Department of Public Health, Health Department of the Alto/Bajo Deba
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Sep 2015 (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 primary aim of PRE-STARt Phase 1 is to pragmatically evaluate and refine a risk assessment tool to identify those children with chronic disease risk factors (including Type 2 Diabetes).
Detailed description
Data will be collected in 5 European Commission countries (500 adolescents in total). A range of biological and lifestyle measures will be collected in order to investigate the adolescent's lifestyle and will include body weight and other anthropometric measurements, blood pressure, blood capillary sample, self-reported physical activity, sedentary behaviour and dietary habits. Their parent/guardian will complete a number of questions to gather information about variables that have been associated with chronic disease (including type 2 diabetes) and include peri-natal history (birth weight, gestational diabetes), socioeconomic status, family health and medical history.
A draft risk tool to identify those children with a 'higher risk' of developing type 2 diabetes in the future has been developed systematic review results and a Delphi procedure. This draft tool will be evaluated and refined. This draft risk tool will be evaluated by independent clinical reviewers against the data collected from the 500 adolescent data sets. The results for each adolescent will be independently reviewed by clinicians who will assign either a "lower" or "higher" risk to each case. The results will be compared to the results from the draft 'PRE-START tool', used to further refine this identification tool using appropriate statistical methods.
The outputs of this study will be a fit for purpose 'PRE-STARt tool' that can be used for recruitment to interventional studies whose primary objective is to reduce the risk of developing chronic disease (including type 2 diabetes) in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UK (Lead Site) | – | Other: No interventionData will be collected from 100 adolescents from each participating site providing clinical data for 500 adolescents providing a cross-sectional cohort from each of the following countries: UK (Lead Site) Germany Portugal Greece Spain (Basque Country) |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Boys and girls who are between 12 and 14 years of age who do not have an existing diagnosis of type 1 or type 2 diabetes.
Key inclusion criteria (3 listed)
- Young people aged between 12-14 years of age
- be willing and able to give assent
- have obtained written parent/guardian consent.
Key exclusion criteria (3 listed)
- are outside the age range of interest (i.e. aged less than 12 years or greater than 14 years of age)
- do not have parental consent or do not give assent
- have an existing diagnosis of type 1 or type 2 diabetes
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 |
|---|---|---|
| No intervention | Other | UK (Lead Site) |
Primary outcome
Chronic disease risk factor - Body mass index (BMI)
Time frame: 12 months
Height and weight will be measured to calculated BMI
8 secondary outcomes
Chronic disease risk factor - waist circumference
Time frame: 12 months
Chronic disease risk factor - blood pressure
Time frame: 12 months
Chronic disease risk factor - glycated haemoglobin (HbA1c)
Time frame: 12 months
Chronic disease risk factor - high density lipoprotein cholesterol
Time frame: 12 months
Chronic disease risk factor - glucose
Time frame: 12 months
Chronic disease risk factor - low density lipoprotein cholesterol
Time frame: 12 months
Chronic disease risk factor - triglycerides
Time frame: 12 months
Chronic disease risk factor - total cholesterol
Time frame: 12 months
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 15 Jan 2019.
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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.
Melanie J Davies, MD principal investigator
University Hospitals, Leicester
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 2 Diabetes and Chronic Disease, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 3 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 15 Jan 2019. 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 United Kingdom. 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?
Chronic disease risk factor - Body mass index (BMI) (time frame: 12 months). 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 15 Jan 2019.