Efficacy of Different Modalities and Frequencies of Physical Exercise 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
- 120
- 主要终点
- fasting plasma glucose
研究概览
简要总结
To assess the efficacy of different modalities and frequencies of physical exercise on glycaemic control in adults with prediabetes. Methods: four-arm, parallel, randomised, controlled, clinical trial, with a total of 120 participants. A total of 90 participants will be randomized in three arms: 1) aerobic exercise, 2) aerobic exercise combined with resistance, and 3) high-intensity intervallic exercise. Moreover, a control group (n=30) will be included to evaluate the effect of any type of intervention versus no intervention. Data collection will be performed at baseline and 15-week of follow-up. Socio-demographic 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. The main dependent variable will be the decrease of fasting plasma glucose. Moreover, a subsample of participants (n=40) will were an accelerometer and a continuous glycaemia monitoring during 7 days, in 2 time points. The impact of the interventions on health will be also evaluated through gene expression analysis in peripheral blood cells, widely used in clinical diagnosis in the same subsample. Discussion: The results of this study will contribute to improving physical exercise prescriptions for diabetes prevention, as well as a better understanding of the response of glucose mechanisms to physical exercise in a population with prediabetes. 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 modalities of physical exercise on fasting plasma glucose in adults with prediabetes.
Secondary Aim. The secondary aims are to evaluate the effect of different physical exercise modalities on the following variables: glycaemic variability measured continuously (24h), normalization of glycaemic values (reversal), body mass index (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).
Design:
The GLYCEX study (GLYcaemic Control with EXercise) is a randomised, parallel, phase II clinical trial with four arms and a duration of 15 weeks. The intervention groups will receive an exercise intervention for 15 weeks, and control group will receive general recommendations of PA, based on world health organization (WHO) recommendations.
Study interventions were reported using the Template for Intervention Description and Replication (TIDieR). The present protocol was elaborated following the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) 2013 State-ment. Reporting of the study will follow the CONSORT statement recommendations on RCTs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The sample size has been calculated to detect significant differences in FPG of at least 2 mg/dl and considering a standard destination of 2 mg/dl in any of the three modalities and a dropout rate of 10%, so 30 subjects will be needed in each group, with a sample of 90 participants. Furthermore, a control group (30 patients) will be added to evaluate the effect of any type of monitored exercise in these patients versus usual clinical practice. Randomization will be done by permuted blocks of 8 in a 1:1:1:1 ratio and participants will be stratified by gender, age and obesity using the open-source Oxford Minimization and Randomization (OxMaR) program
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
- •Overweight (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
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
fasting plasma glucose
时间窗: 15 weeks of intervention
Changes in fasting plasma glucose, revers to normoglycaemia levels
次要结局
- body composition (measured by bioimpedance)(15 weeks of intervention)
- glycaemic variability (measured with continuos glucose monitor: Time in range and MAGE)(15 weeks of intervention)
- HbA1c(15 weeks of intervention)
- Systolic and Diastolic Blood Pressure(15 weeks of intervention)
- transcriptomic biomarkers in blood (PBC)(15 weeks of intervention)
- Triglycerides(15 weeks of intervention)
研究者
Josep1
Full time teacher and researcher
University of the Balearic Islands