Investigating the Response of Glycaemic Excursions in Type-2 Diabetes to Interrupting Prolonged Sedentary Behaviour (Sitting)
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 主要终点
- Postprandial glucose excursions measured with Area under curve
研究概览
简要总结
Type-2 diabetes, a common non-infectious disease, is the result of impaired insulin function and insulin production in the body. In type-2 diabetic patients, postprandial glucose control, lipid control and reduction of insulin resistance are crucial to deter the development of diabetes related complications (e.g. retinopathy, nephropathy, neuropathy and cardiovascular diseases), pancreatic β cells failure, morbidity and mortality. Currently, diet, exercise and standard oral medicines are used to treat type-2 diabetes. However, providing the most effective treatment to control postprandial glucose and lipid; and to preserve the pancreatic β cells is challenging because poor metabolic profiles are still detected in type-2 diabetic patients. Therefore, understanding the factors influencing the poor metabolic profiles and adjunct therapy to manage type-2 diabetes are really important to tackle this disease.
In modern society, people are spending most of their waking time in sedentary behaviour, which is primarily prolonged sitting. Prolonged sedentary time is associated with increased postprandial glucose, lipid and insulin resistance. In contrast, frequent interruption of prolonged sitting with short light activity break reduces postprandial glucose, triglyceride cholesterol and insulin resistance. However, how frequently patients should interrupt sitting, potential longer-term effect of short activity break on reduction of postprandial glucose, triglyceride cholesterol and insulin resistance, and the knowledge, beliefs and experiences on the use of technology to decrease sedentary behaviour and improve glycaemic control are not investigated in type-2 diabetic patients. Therefore, it would be relevant to investigate this to prove the therapeutic role of frequent short activity break in sedentary time in the management of type-2 diabetes.
Primary Research Objective:
- To investigate the dose-response effect of frequency/number of light intensity walking breaks of sitting on postprandial glucose, insulin, C-peptide and triglyceride cholesterol level.
- To investigate the potential longer-term effect of light intensity walking breaks of sitting on glucose control using 24-h glucose data.
Secondary Research Objectives: The secondary objectives are
- To obtain data to inform the development of a future feasibility trial investigating the feasibility, compliance, adherence and longer-term effect of different frequencies of light intensity walking breaks in sitting time on glycaemic excursions in free-living.
- To explore the knowledge, beliefs and experiences of those with Type 2 diabetes on the use of technology to decrease sedentary behaviour and improve glycaemic control, that could be used in the feasibility trial
详细描述
Overall Study Design:
The study is a three-treatments, two-periods balanced incomplete block trial. Participants will be randomized in blocks completing to two of the three treatment conditions (lab interventions A, B and C below), in different sequence. The three treatment conditions are;
- Intervention A: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min
- Intervention B: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min
- Intervention C: Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min There will be 5 days of washout period between each intervention. Each participant will complete two of three treatment conditions within 15 days of experimental period (4 days of pre monitoring period - 1 day of lab intervention - 5 days of washout period - 1 day of lab intervention - 4 days of post monitoring period).
The participants will wear the Abbot FreeStyle Libre continuous glucose monitoring device and the activPAL (activity monitor) throughout the 15 days of experimental period.
Pre-monitoring period: On day 1 of the experimental period, participants will be requested to come to the Diabetes Clinic (Ayr hospital). Baseline anthropometric data (e.g. age, gender, height, weight and body mass index) and drug history will also be recorded by the researcher. The participant will then be fitted with the Abbot FreeStyle Libre continuous glucose monitoring device (sensor) and the activPAL, activity monitor. We will also provide the participant with 24 h diet recall forms so that they can record their daily food intake throughout study period (15 days). After that the participants will return home, instructed to scan their blood glucose every 8 h using the FreeStyle Libre reader they will be supplied with, to record daily food intake, to refrain from smoking, alcohol, caffeine and moderate to vigorous physical activity throughout the experimental period, and to come back on day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with type 2 diabetes for less than 10 years
- •Individuals aged 35-60 years
- •Individuals receiving metformin or diet control
- •Non-smokers
- •Overweight and obese individuals (BMI 25-35 kg/m2)
- •Individuals with an HbA1c between >7%
- •Individuals with BP below 160/90mmHg
排除标准
- •Individuals unable or unwilling to consent
- •Individuals under the age of 35 years and over the age of 60 years at study enrolment
- •Patients on sulphonylurea or other oral hypoglycaemic drugs therapy except metformin
- •Individuals with hepatic or renal dysfunction
- •Individuals with body mass index greater than 35
- •Individuals suffering from cancer, cardiovascular diseases, cirrhosis, hepatitis and renal disease
- •Pregnant Individuals
- •Individuals who smoke
- •Individuals who are alcohol and drug abusers
- •Individuals with a blood pressure ≥160/90mmHg
- •Individuals diagnosed with anaemia (Hb<12g/dl in women and <13 g/dl in men)
- •Individuals taking medicines which can interfere with the glucose metabolism (e.g. anticoagulants, oral contraceptives, steroid, thiazide, β-blocker, NSAID, anti-fungal, hormonal therapy, psychotropic drugs)
- •Individual taking drugs for glycaemic control in excess of standard care highlighted by the SIGN guideline 116.
结局指标
主要结局
Postprandial glucose excursions measured with Area under curve
时间窗: 8 hours
Dose-response relationship between frequencies of short light activity breaks in sedentary time and postprandial glucose excursions
次要结局
- Insulin, C-peptide and triglyceride cholesterol plasma level during the intervention measured with Area under curve(8 hours)
- 24 hours glucose profile measured with continuous glucose monitor LifeStyle Libre(24 hours)
- Qualitative exploration of the knowledge, beliefs and experiences of those with type 2 diabetes on the use of technology to decrease sedentary behaviour and improve glycaemic control(1 hour)