Prevention Strategies for Adolescents at Risk of Diabetes

Type 2 Diabetes Clinical Trial

— PRE-STARt  

Official title:

Prevention Strategies for Adolescents at Risk of Diabetes - Validation of a Risk Tool for Young People Aged 12 - 14 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545140
• Other study ID #: 173431
• Status: Completed
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2019
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 14 Years

Eligibility

Inclusion Criteria:

• Young people aged between 12-14 years of age

• be willing and able to give assent

• have obtained written parent/guardian consent.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester	Leicester

Sponsors (12)

Lead Sponsor

Collaborator

University Hospitals, Leicester

Alexander Technological Educational Institute, Thessaloniki, Greece, Associacao Protectora dos Diabeticos de Portugal, Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Basque Government Department of Public Health, Diabetes Centre of Paediatrics P&A, Health Department of the Alto/Bajo Deba, Spain, Primary Care Centre Egia, San Sebastian, Spain, Technische Universität Dresden, The Algarve Regional Health Administration, University of Leicester, University of Leipzig

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Risk tool refinement	A draft risk tool to identify those children with a 'higher risk' of developing type 2 diabetes in the future that has been developed systematic review results and a Delphi procedure. Each adolescent will complete a diet and lifestyle questionnaire about their physical activity, sedentary behaviour and dietary habits and the parent/guardian will complete a questionnaire about their family health history and about their child's early years (including gestational period, birth weight, whether they were breast or bottle fed). This draft tool will be evaluated and refined using these data and the data from the assessments mentioned in 1-9. The draft risk tool will then be refined based on data from the 500 adolescents using appropriate statistical methods resulting in an externally validated risk tool that can be used to screen young people aged between 12-14 years for being at risk of developing of type 2 diabetes in the future.	18 months
Primary	Chronic disease risk factor - Body mass index (BMI)	Height and weight will be measured to calculated BMI	12 months
Secondary	Chronic disease risk factor - waist circumference		12 months
Secondary	Chronic disease risk factor - blood pressure		12 months
Secondary	Chronic disease risk factor - glycated haemoglobin (HbA1c)		12 months
Secondary	Chronic disease risk factor - high density lipoprotein cholesterol		12 months
Secondary	Chronic disease risk factor - glucose	Fasted and/or unfasted	12 months
Secondary	Chronic disease risk factor - low density lipoprotein cholesterol	Calculated	12 months
Secondary	Chronic disease risk factor - triglycerides		12 months
Secondary	Chronic disease risk factor - total cholesterol		12 months