Efficacy of Different Modalities and Frequencies of Physical Ex-ercise on Glucose Control in People With Prediabetes (GLYCEX Randomised Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- MAGE
研究概览
简要总结
Aim: To assess the efficacy of different frequencies of physical exercise on glycaemic control in adults with prediabetes. Methods: parallel, randomised, controlled, clinical trial will be carried out, with a total of 90 participants. Exercise modality that showed the best glycaemic control in first phase of GLYCEX study (NCT05612698) will be used. Participantds will be randomised in 3 groups: 1) frequency of 5 days/week, 2) frequency of 3 days/week and 3) frequency of 2 days/week. Data collection will be performed at baseline and after 15-weeks of follow up. Sociodemographic data, medication, comorbidity, blood biochemical parameters, blood pressure, anthropometric measurements, body composition, physical activity, sedentary lifestyle, diet, smoking, alcohol consumption, quality of life and sleep questionnaires will be collected. Physical activity, sedentary behaviour and sleep will be further determined with an accelerometer, and continuous glycaemia will be determined with a glycaemic monitor, both during seven days, in two time points. The main dependent variable will be the reduction of the mean amplitude of glycaemic excursions. The impact of the interventions on health will also be evaluated through gene expression analysis in peripheral blood cells. Discussion: The results of this study will contribute to better understanding of the response of glucose mechanisms to physical exercise in a population with prediabetes as well as improving physical exercise prescriptions for diabetes prevention. Increasing glycaemic control in people with prediabetes through physical exercise offers an opportunity to prevent diabetes and reduce associated comorbidities and health costs.
详细描述
Principal Aim. The main aim of the preset study is to compare the efficacy of 3 different frequencies of physical exercise on MAGE in adults with prediabetes.
Secondary Aim: The secondary aims are to evaluate the effect of different physical exercise frequencies on the following variables: FPG, glycaemic variability measured continuously (24h), normalization of glycaemic values (reversal), BMI, body composition (percentage and grams of total fat mass and muscle mass; visceral adipose tissue (VAT) waist circumference, lipid profile, inflammation markers, blood pressure and sleep duration and quality; transcriptomic markers of metabolic health assessed in peripheral blood cells (PBC).
Participants Participants' identification and recruitment will be carried out at different primary care centres from Mallorca, Spain, that formally agree to participate in this phase, and through posters distributed at different points of interest: hospitals, universities, primary care cen-ters, patient associations, etc. Likewise, it will also be disseminated through social net-works, such as Twitter. Interested patients will receive the information sheet, sign the writ-ten informed consent and eligibility criteria will be verified.
Sample size and randomization The sample size has been calculated to detect significant differences in MAGE of at least 1.5 mg/dl and considering a standard deviation of 1.4 mg/dl in any of the three modalities and a dropout rate of 20%, so 30 subjects will be needed in each group, with a sample of 90 participants. Randomization will be done by permuted blocks of 8 in a 1:1:1 ratio and stratified by prognostic factors: gender, age and obesity using the open-source Oxford Minimization and Randomization (OxMaR) program.
Description of intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-65 years
- •with overweight or obesity (BMI >25 and <35 Kg/m2)
- •inactive (<150 min PA/week)
- •with prediabetes (fasting blood glucose 100-126 mg/dl)
- •who have signed the informed consent will be included.
排除标准
- •People with uncontrolled hypertension
- •diagnosis of T2D or oral anti-diabetic prescription
- •active cancer
- •terminal illness
- •cognitive impairment
- •pregnancy
- •cardiovascular disease
- •inability to perform moderate-vigorous physical exercise for the next 3 months
- •major surgery or hospital admission in the last 3 months
- •haematological disease that interferes with HbA1c determination
- •presence of any condition (medical, psychological, social or geographical) current or anticipated that limits participation in the study
- •participation in another clinical trial will be excluded.
结局指标
主要结局
MAGE
时间窗: 15 weeks of intervention
mean amplitude of glycaemic excursions (MAGE), measured with a continuous blood glucose monitor during 14 consecutive days
次要结局
- FGP mg/dl(15 weeks of intervention)
- transcriptomic biomarkers in blood(15 weeks of intervention)
- TG mg/dl(15 weeks of intervention)
- TIR(15 weeks of intervention)
- Blood pressure mmHg(15 weeks of intervention)
- waist circumference (cm)(15 weeks of intervention)
- quality of life (self-reported questionnaire)(15 weeks of intervention)
- HbA1c (%)(15 weeks of intervention)
- body composition (grams and percentage)(15 weeks of intervention)
研究者
Josep1
Full time teacher and researcher
University of the Balearic Islands