EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL ACTIVITY FOR GLYCOSYLATED HB CONTROL IN PREDIABETICS: CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin (HbA1c)
研究概览
简要总结
Diabetes represents a substantial burden on health care systems. People with prediabetes IGT (impaired glucose tolerance) or IFG (impaired fasting glucose) are at high risk of developing diabetes, and up to 50% progress to diabetes within 5 years.
OBJECTIVE: To evaluate the effectiveness of a triple intervention (physical activity and ordered healthy diet) to improve glycosylated hemoglobin control in prediabetic patients.
MATERIAL AND METHODOLOGY: Randomized, open, controlled clinical trial with routine clinical practice (health advice for physical activity and healthy diet). Study population: obese or overweight patients of the OSI Araba aged 35-70 years who are in the contemplation stage.
Response assessment: Primary variable: glycosylated hemoglobin; Secondary variables: Body Mass Index (BMI) (kg/cm2); blood pressure (mm Hg); satisfaction questionnaire score; physical exercise index (IPAQ) (METs). Statistical analysis: The analysis of the main variable (change in HbA1c at 6 months between both groups) will be assessed by analysis of covariance, ANCOVA, adjusting for baseline HbA1c. Sample size: 41 patients per arm (+30% to cover losses to follow-up).
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
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prediabetics with glycosylated hemoglobin (HbA1c) 5.7-6.4 (24, 38) and signing informed consent.
排除标准
- •Presence of physical or psychological illnesses that prevent physical activity; participation in another research project; pregnancy or breastfeeding; patients undergoing dietary or pharmacological treatment for weight loss; history of myocardial infarction or stroke; diabetic, taking drugs for diabetes mellitus and taking drugs such as Gliflozin for pathologies other than diabetes mellitus.
- •of physical or psychological illnesses that prevent physical activity; participation in another research project; pregnancy or breastfeeding; patients undergoing dietary or pharmacological treatment for weight loss; history of myocardial infarction or stroke; diabetic, taking drugs for diabetes mellitus and taking drugs such as Gliflozin for pathologies other than diabetes mellitus.
研究组 & 干预措施
INTERVENTIONAL GROUP
Health advice and triple intervention: 15 ml apple cider vinegar diluted in a glass of water before meals, order in the sequence of meals (sequence of food intake: first vegetables, second proteins, third fats and finally carbohydrates) and physical activity immediately after meals.
Description of all interventions:
Patients in both groups: all patients will receive health advice on sports practice from the WHO, Osakidetza and the Basque Government (42-44).
Likewise, the nurse will give healthy eating recommendations according to the Osakidetza guide (41):
1.1 Recommendation sports practice: ecommendation 1:
>>All persons aged 18 years and older should accumulate a minimum of 150 minutes per week of moderate aerobic physical activity, or 75 minutes of vigorous aerobic physical activity each week, or an equivalent combination of moderate and vigorous activities. Exercise should be in sessions of at least 10 minutes.
Recommendation 2: Twice or more times per week, it is advisable to
干预措施: A TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY (Combination Product)
CONTROL GROUP
Patients will receive the same attention as provided in routine clinical practice,
结局指标
主要结局
Glycated hemoglobin (HbA1c)
时间窗: At baseline, 3 and 6 months
Glycated hemoglobin (HbA1c)
次要结局
- Satisfaction of patients(At 6 months)
- BMI (kg/cm2)(At baseline, 3 and 6 months)
- Physical exercise index(At baseline, 3 and 6 months)
- Compliance with the triple dietary intervention(At 3 and 6 months)
- Percentage of patients who reach normoglycemia (HbA1c < 5.7)(At 3 and 6 months)
研究者
ANTXON APIÑANIZ
GENERAL PRACTITIONNER
Osakidetza