Comparative Effects of Exercise and Metformin on Glycemic Control in Prediabetic Adults: A Community-Based, Open-Label, Randomized Trial in a Low-Resource Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Change in Glycated Hemoglobin (HbA1c) from Baseline to 12 Weeks
研究概览
简要总结
This study is being done to compare the effect of regular exercise and metformin in people who have prediabetes. It is a community-based, open-label, randomized trial in which eligible participants will be divided into two groups. One group will do moderate physical exercise, and the other group will take metformin for 12 weeks. We will check their fasting blood sugar and HbA1c before and after the treatment to see which method works better for controlling sugar levels. The study is being done in a low-resource community setup to see which option is more practical and effective in real-life Pakistani settings.
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
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 59 years
- •Diagnosed with prediabetes based on ADA criteria (FPG: 100-125 mg/dL or HbA1c: 5.7-6.4%)
- •Stable HbA1c levels (no significant fluctuation in the last 3 months)
- •Body Mass Index (BMI) less than 30 kg/m²
- •Willing and able to provide written informed consent
- •Willing to participate in the assigned intervention (exercise or metformin) for 12 weeks
- •Residing within the community and able to attend scheduled follow-ups
排除标准
- •Age 60 years or older
- •Diagnosis of Type 2 Diabetes Mellitus (T2DM) or use of anti-diabetic medications
- •Family history of diabetes in first-degree relatives (parent or sibling)
- •Known cardiovascular, renal, or hepatic disease
- •Pregnancy or lactation
- •Physical disability or limitation that would interfere with performing moderate-intensity exercise
- •Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)
- •Known allergy or contraindication to metformin
- •Alcohol or substance abuse
研究组 & 干预措施
Exercise Group
Moderate aerobic activity (e.g., brisk walking) for 30-45 minutes/day, 5 days/week, for 12 weeks.
干预措施: Moderately intense exercise (Behavioral)
Metformin Group
Participants will receive oral metformin 500 mg twice daily for 12 weeks.
干预措施: MetFORMIN 500 Mg Oral Tablet (Drug)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c) from Baseline to 12 Weeks
时间窗: Baseline and 12 week
HbA1c (%) will be measured to assess glycemic improvement following 12 weeks of intervention.
次要结局
- Weight change(Baseline to 12 weeks)
研究者
Asad Ullah Jan
Consultant Psychiatrist
Combined Military Hospital Nowshera