Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Screening for Glucose Intolerance and Development of a Lifestyle Education Programme for Prevention of Type 2 Diabetes in a Population With Learning Disabilities
Verified date | July 2015 |
Source | University of Leicester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Observational |
People with learning (intellectual) disabilities have more health problems than the rest of
the populationÍž they are less likely to access help and have lifestyles that may increase
their risk of getting diabetes (for example, poor diet and lack of physical activity).
People with learning disabilities may also be prescribed drugs or have certain medical
conditions (such as Down's syndrome) which can make their chances of getting diabetes
greater.
Diabetes is a long-term condition, which can cause damage to the eyes, heart, kidneys,
nerves and feet. Impaired glucose regulation happens when sugar levels in the blood are
higher than normal but are not high enough to be diagnosed with diabetes. People with
impaired glucose regulation are more likely to develop diabetes, heart disease and stroke in
the future. If people with impaired glucose regulation make changes to their lifestyle (diet
and exercise) they can prevent or delay getting diabetes.
The aim of this study is to screen people with learning disabilities for diabetes and
impaired glucose regulation. The investigators also want to find out the best way to give
people with learning disabilities some education around healthy lifestyles (for example,
eating and exercise) to help with prevention of diabetes and cardiovascular disease.
Therefore, the investigators also aim to develop a lifestyle education programme that is
suitable for use in this population and test whether it is feasible and acceptable.
Status | Completed |
Enrollment | 930 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 74 Years |
Eligibility |
Inclusion Criteria: - Volunteer has a confirmed learning disability (permanent intellectual impairment); - Registered with a general practice in Leicester, Leicestershire or Rutland, UK; - Participant and/or carer has sufficient English language skills to enable fully informed consent to be obtained. Exclusion Criteria: - Confirmed diagnosis of Type 2 diabetes or Type 1 Diabetes; - Malignancy or terminal illness; - Pregnancy or breast feeding; - Severe systemic disease that may interfere with measurement and interpretation of HbA1c. |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United Kingdom | Diabetes Research Centre, University of Leicester | Leicester |
Lead Sponsor | Collaborator |
---|---|
University of Leicester |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glycosylated haemoglobin (HbA1c) | Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation | Baseline screening appointment | No |
Primary | Plasma glucose | Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation | Baseline screening appointment | No |
Secondary | Physical activity levels (including sedentary behaviour) | measured by accelerometer - only for a small sub-group | Baseline screening appointment | No |
Secondary | Obesity levels | body mass index and waist size | Baseline screening appointment | No |
Secondary | Blood pressure | systolic and diastolic | Baseline screening appointment | No |
Secondary | Lipids levels | total cholesterol, LDL, HDL, triglycerides | Baseline screening appointment | No |
Secondary | Dietary/nutritional intake | food groups and fruit and vegetable intake | Baseline screening appointment | No |
Secondary | Cardiovascular risk | Framingham risk score | Baseline screening appointment | No |
Secondary | Health related quality of life | EQ-5D | Baseline screening appointment | No |
Secondary | Behavioural disorders | Aberrant Behaviour Checklist | Baseline screening appointment | No |
Secondary | Psychiatric disorders | PAS-ADD checklist | Baseline screening appointment | No |
Secondary | Depression | Glasgow Depression Scale and Carer Supplement | Baseline screening appointment | No |
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