跳至主要内容
临床试验/CTRI/2025/02/080245
CTRI/2025/02/080245Not Applicable2 期

Synergistic Effects of Metformin and Aerobic Exercises on Osteocalcin, Insulin, IL-6, Glucose Levels and BMI on Patients with Diabetes Mellitus Type 2

Muhammad Institute of Medical and Allied sciences Multan1 个研究点 分布在 1 个国家目标入组 377 人开始时间: 2025年2月20日最近更新:

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

发起方
Muhammad Institute of Medical and Allied sciences Multan
申办方类型
Other [Student fund]
责任方
Principal Investigator
主要研究者

Dr Imran Ahmad Khan

Muhammad Nawaz Sharif University of Agriculture Multan

研究点 (1)

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