Screening for Glucose Intolerance and Development of a Lifestyle Education Programme for Prevention of Type 2 Diabetes in a Population With Learning Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 930
- 试验地点
- 1
- 主要终点
- Plasma glucose
研究概览
简要总结
People with learning (intellectual) disabilities have more health problems than the rest of the population; 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.
详细描述
Background -Adults with learning (intellectual) disabilities tend to have more health problems than the general population and are less likely to access help. Additionally, evidence suggests that due to a combination of lifestyle factors (e.g. poor diet, lack of physical activity), associated medical problems, and certain types of prescribed medication, people with learning disabilities may be at increased risk of developing type 2 diabetes and cardiovascular disease. Our overall aim is to undertake a programme of research that improves our knowledge and understanding of screening for impaired glucose regulation and type 2 diabetes in a population with learning disabilities, and to develop a lifestyle education programme for prevention of type 2 diabetes that is suitable for use in this population.
SCREENING PROGRAMME
Aim - The main programme of work consists of a large diabetes screening programme. The primary aim of the screening study is to evaluate the feasibility and clinical and cost effectiveness of a screening programme for identifying undiagnosed type 2 diabetes and impaired glucose regulation that is suitable for use in a population with learning disabilities.
Methods - A variety of approaches will be used to recruit people to the screening study: General practices will be approached first for participation in this study. If the practice does not agree, then the investigators will seek to approach eligible people on the Leicestershire Learning Disabilities Register. Learning disabilities consultants will also approach people face to face when attending for outpatient clinic appointments. Additionally, if individuals with learning disabilities (and/or their carer) contact the STOP Diabetes team to express an interest in the study, they will be given an invitation.
- Volunteers will be asked to attend an appointment(s) where consent will be obtained and biomedical and demographic data collected. The consent process and data collection will be staged and people may need to attend between one to three appointments to complete.
- People who are found to have type 2 diabetes or impaired glucose regulation will be asked to see their GP for care.
- At every stage, reasonable adjustments will be made to take into account people's communication needs and decision making capacity. This may include involving a carer or a
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Plasma glucose
时间窗: Baseline screening appointment
Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation
Glycosylated haemoglobin (HbA1c)
时间窗: Baseline screening appointment
Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation
次要结局
- Dietary/nutritional intake(Baseline screening appointment)
- Health related quality of life(Baseline screening appointment)
- Physical activity levels (including sedentary behaviour)(Baseline screening appointment)
- Obesity levels(Baseline screening appointment)
- Lipids levels(Baseline screening appointment)
- Blood pressure(Baseline screening appointment)
- Behavioural disorders(Baseline screening appointment)
- Psychiatric disorders(Baseline screening appointment)
- Depression(Baseline screening appointment)
- Cardiovascular risk(Baseline screening appointment)