Synergistic Effects of Metformin and Aerobic Exercises on Osteocalcin, Insulin, IL-6, Glucose Levels and BMI on Patients with Diabetes Mellitus Type 2
试验速览
- 阶段
- 2 期
- 状态
- Not Applicable
- 发起方
- 入组人数
- 377
- 试验地点
- 1
- 主要终点
- Osteocalcin levels will be measured using serum concentration assays (ELISA).
研究概览
简要总结
Patients with diabetes mellitus type 2 will come to Muhammad physical therapy clinic and rehabilitation centre, Multan. And after their consent, we will start our study on them.
Data collection procedure
Data will be collected after getting the approval from ethical committee, providing information to the patients Informed consent will be taken from the patient and the attendant.
Osteocalcin levels will be measured using serum concentration assays (ELISA).
Insulin levels will be assessed through fasting insulin tests
Interleukin-6 (IL-6) levels will be quantified via serum cytokine assays (ELISA).
Blood Glucose levels (Random and fasting blood glucose level)will be monitored using fasting blood glucose tests
Hemoglobin A1c (HbA1c) for long-term glycemic control.
Body Mass Index (BMI) will be calculated using height and weight measurements.
Diabetes self-management will be assessed using the Diabetes Self-Management Questionnaire (DSMQ) , while
Quality of life will be evaluated using the Diabetes Quality of Life (DQoL)
Lipid profile ( LDH,HDL,Triglycerides)
Blood pressure
VO2 max
Physical fitness will be evaluated using the 6-minute walk test
Interventions
Metformin dosage
Dosage of 1000 mg/day of metformin is given to patients of all groups.
Physical therapy interventions
The treatment regime distributed in 6-week period 5 days per week exercise sessions lasted for 30 minutes in group B and C. Aerobic exercises include walking, cycling and elliptical training.
Walking 5 days per week includes 5 min slow walking,20 min brisk,5 min cools down and stretching exercises
Cycling exercise includes 5 min slow ,20-30 min moderate,5 min easy and stretching
Elliptical training includes 5 min warm up, 5 min low intensity exercise,10 min moderate intensity exercise, cool down and stretching
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •20-60 years
- •Patients with T2DM
- •Both genders.
排除标准
- •Vascular neoplasia
- •Fibromyalgia
- •Radiculopathy
- •Neuropathy
- •Joint fractures
- •Vestibular problems
- •Congenital disorders.
结局指标
主要结局
Osteocalcin levels will be measured using serum concentration assays (ELISA).
时间窗: 6 weeks
Insulin levels will be assessed through fasting insulin tests
时间窗: 6 weeks
Interleukin-6 (IL-6) levels will be quantified via serum cytokine assays (ELISA).
时间窗: 6 weeks
Blood Glucose levels (Random and fasting blood glucose level)will be monitored using fasting blood glucose tests
时间窗: 6 weeks
Hemoglobin A1c (HbA1c) for long-term glycemic control.
时间窗: 6 weeks
Body Mass Index (BMI) will be calculated using height and weight measurements.
时间窗: 6 weeks
Diabetes self-management will be assessed using the Diabetes Self-Management Questionnaire (DSMQ) , while
时间窗: 6 weeks
Quality of life will be evaluated using the Diabetes Quality of Life (DQoL)
时间窗: 6 weeks
次要结局
- Lipid profile ( LDH,HDL,Triglycerides)(Blood pressure)
研究者
Dr Imran Ahmad Khan
Muhammad Nawaz Sharif University of Agriculture Multan
