Effects of a Multimodal Exercise Program Combined with a High-Protein Diet on Glycemic Control in Older Adults with Type 2 Diabetes Mellitus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Glycemic control (HbA1c%)
研究概览
简要总结
This randomized controlled trial will examine the effects of a 12-week Multimodal Exercise Program (MEP), with or without a High-Protein Diet (HPD), on glycemic control in older adults (aged 60+) with type 2 diabetes mellitus (T2DM). Participants in the experimental group will receive MEP combined with an HPD (40% carbohydrates, 30% protein, 30% fat), while the control group will receive MEP alone. The MEP will consist of supervised and home-based sessions focusing on aerobic and flexibility exercises, conducted three times per week. The primary outcome will be HbA1c%, while secondary outcomes will include body composition, lipid profile, physical function, and quality of life. The trial will aim to determine whether the addition of a high-protein diet enhances the metabolic and functional benefits of exercise in older adults with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •The inclusion criteria will: (1) meeting the diagnostic criteria for diabetes based on the American Diabetes Association (ADA) guidelines, (2) age over 60 years, for both males and females, (3) a diagnosis of Diabetes Mellitus (DM) for more than 3 years, (4) fasting plasma glucose level greater than 7 mmol/L and (5) willingness to participate in the study.
排除标准
- •Participants will be excluded if: (1) they had chronic inflammatory or pathological conditions, (2) they were pregnant, or (3) they were currently undergoing treatment with antidepressants.
结局指标
主要结局
Glycemic control (HbA1c%)
时间窗: At baseline, 12 weeks and 24 weeks
次要结局
- Body weight (kg), Body mass index (kg/m2), Waist circumference (cm), Fasting blood sugar level (mmol/L), HDL cholesterol (mg/dl), LDL cholesterol (mg/dl), Total cholesterol (mg/dl), Triglycerides (mg/dl), Six-minute walk test (distance in metres), and Quality of life (SF-36)(At baseline, 12 weeks and 24 weeks)
研究者
Kazi Md Azman Hossain
Jashore University of Science and Technology (JUST), Jashore