A Randomized Trial Evaluating the Effects of One-Year Caloric Restriction and 12-Week Exercise Training Intervention in Obese Adults With Type 2 Diabetes: Emphasis on Metabolic Control and Resting Metabolic Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 主要终点
- Change from baseline Glycated Hemoglobin (HbA1c) at 6 months
研究概览
简要总结
Diabetic patients with uncontrolled disease are often characterized by increased energy expenditure and could thus present a high resting metabolic rate (RMR). Lifestyle interventions aimed at improving glucose control in these patients may lead to reductions of futile pathways, resulting in lower rates of energy expenditure, and paradoxically to making it more difficult to lose weight. However, only few studies investigated how exercise could influence patients' RMR and results are still not unanimous. In this study, we aim to investigate the effects on metabolic health of a combined dietary intervention and 12-week exercise training in obese adults with type 2 diabetes.
详细描述
Although a number of exercise training interventions have been proposed to type 2 diabetes patients, the current clinical practice demonstrates that most patients are still sedentary and with excess body weight. A negative balance between energy intake and energy expenditure is crucial to reduce excess body weight. However, diabetic patients with uncontrolled disease are often characterized by increased energy expenditure and could thus present a high resting metabolic rate (RMR). Lifestyle interventions aimed at improving glucose control in these patients may lead to reductions of futile pathways, resulting in lower rates of energy expenditure, and paradoxically to making it more difficult to lose weight. However, no robust evidence has been collected on this issue, and the few studies that investigated how exercise could influence patients' RMR have not shown unanimous results, especially concerning combined dietary and physical activity interventions.
This open-label randomized trial in obese adults with type 2 diabetes aims to investigate the effects of a 1-year caloric restriction and 12-week exercise training intervention on metabolic health, RMR and VO2max.
In particular, eligible type 2 diabetes patients of our clinic will be invited to participate in a short lifestyle intervention (LSI). LSI will consist of four weekly group-led lessons lasting 60-90 minutes in which specialized professionals will educate patients on specific dietary and physical activity recommendations for improving health and metabolic control.
After this month, patients will be randomly assigned either to: 1) 1-year caloric restriction with an immediate start of 12-week supervised structured exercise training (SSET) (Early-SSET intervention), followed by no exercise at health centers for 3 months; or: 2) 1-year caloric restriction with no exercise at health centers for 3 months and then a 12-week SSET from month 4 to month 6 (Late-SSET intervention). During the last 6 months participants' activity will be unrestricted.
Type 2 diabetic and obese adult volunteers will be recruited and screened through medical history, physical examination and biochemical analyses.
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
- None
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •age 30 to 64 years
- •less than 60 min aerobic exercise/week
- •absence of acute diseases
- •no current treatment with insulin or sulfonylureas
排除标准
- •Body mass index (BMI)<28
- •HbA1c<6%
- •Recent acute diseases, severe infections, trauma or surgery
- •Uncontrolled hypertension or hyperglycemia
- •Evidence of advanced cardiovascular, renal or hepatic diseases
- •Contraindication to exercise
- •Body weight change of more than 3% within the last 6 months
- •Medication changes within the last 3 months
研究组 & 干预措施
Caloric restriction and early SSET
Patients will participate to a short lifestyle intervention (LSI), consisting of four weekly group-led lessons lasting 60-90 minutes to educate them on specific dietary and physical activity recommendations for improving health and metabolic control. At the end of the 1-month LSI, participants will start a caloric restriction and early exercise training (SSET) during the first 12-week, followed by no exercise at health centers for 3 months. Between the 6- and the 12-month assessments, participants will continue caloric restriction and will be encouraged to freely exercise.
干预措施: Caloric restriction (Behavioral)
Caloric restriction and early SSET
Patients will participate to a short lifestyle intervention (LSI), consisting of four weekly group-led lessons lasting 60-90 minutes to educate them on specific dietary and physical activity recommendations for improving health and metabolic control. At the end of the 1-month LSI, participants will start a caloric restriction and early exercise training (SSET) during the first 12-week, followed by no exercise at health centers for 3 months. Between the 6- and the 12-month assessments, participants will continue caloric restriction and will be encouraged to freely exercise.
干预措施: Exercise training (Behavioral)
Caloric restriction and late SSET
Patients will participate to a short lifestyle intervention (LSI), consisting of four weekly group-led lessons lasting 60-90 minutes to educate them on specific dietary and physical activity recommendations for improving health and metabolic control. At the end of the 1-month LSI, participants will start a one-year caloric restriction with no exercise at health centers for 3 months, and then a 12-week exercise training (SSET). Between the 6- and the 12-month assessments, participants will continue caloric restriction and will be encouraged to freely exercise.
干预措施: Caloric restriction (Behavioral)
Caloric restriction and late SSET
Patients will participate to a short lifestyle intervention (LSI), consisting of four weekly group-led lessons lasting 60-90 minutes to educate them on specific dietary and physical activity recommendations for improving health and metabolic control. At the end of the 1-month LSI, participants will start a one-year caloric restriction with no exercise at health centers for 3 months, and then a 12-week exercise training (SSET). Between the 6- and the 12-month assessments, participants will continue caloric restriction and will be encouraged to freely exercise.
干预措施: Exercise training (Behavioral)
结局指标
主要结局
Change from baseline Glycated Hemoglobin (HbA1c) at 6 months
时间窗: 6 months
Venous blood samples will be collected at morning between 7-9 a.m. for the analysis of Glycated Hemoglobin, performed following standard quality-control procedures.
次要结局
- Change from baseline Fat-free mass at 6 months(6 months)
- Change from baseline Fat-free mass at 12 months(12 months)
- Change from baseline android to gynoid percent fat ratio at 3 months(3 months)
- Change from baseline android to gynoid percent fat ratio at 6 months(6 months)
- Change from baseline android to gynoid percent fat ratio at 12 months(12 months)
- Change from baseline fasting plasma glucose at 3 months(3 months)
- Change from baseline fasting plasma glucose at 6 months(6 months)
- Change from baseline fasting plasma glucose at 12 months(12 months)
- Change from baseline HDL cholesterol at 3 months(3 months)
- Change from baseline HDL cholesterol at 6 months(6 months)
- Change from baseline HDL cholesterol at 12 months(12 months)
- Change from baseline total cholesterol at 3 months(3 months)
- Change from baseline total cholesterol at 12 months(12 months)
- Change from baseline Resting Metabolic Rate at 3 months(3 months)
- Change from baseline Resting Metabolic Rate at 6 months(6 months)
- Change from baseline Resting Metabolic Rate at 12 months(12 months)
- Change from baseline Body mass index at 3 months(3 months)
- Change from baseline Body mass index at 6 months(6 months)
- Change from baseline Body mass index at 12 months(12 months)
- Change from baseline Fat-free mass at 3 months(3 months)
- Change from baseline triglycerides levels at 3 months(3 months)
- Change from baseline triglycerides levels at 6 months(6 months)
- Change from baseline total cholesterol at 6 months(6 months)
- Change from baseline triglycerides levels at 12 months(12 months)
- Change from baseline serum creatinine at 3 months(3 months)
- Change from baseline serum creatinine at 6 months(6 months)
- Change from baseline serum creatinine at 12 months(12 months)
- Change from baseline urinary albumin-to-creatinine ratio at 3 months(3 months)
- Change from baseline urinary albumin-to-creatinine ratio at 6 months(6 months)
- Change from baseline urinary albumin-to-creatinine ratio at 12 months(12 months)
- Change from baseline maximal aerobic power at 3 months(3 months)
- Change from baseline maximal aerobic power at 6 months(6 months)
- Change from baseline maximal aerobic power at 12 months(12 months)
- Change from baseline Glycated Hemoglobin (HbA1c) at 3 months(3 months)
- Change from baseline Glycated Hemoglobin (HbA1c) at 12 months(12 months)