Comparison of Glucophage Plus Myo-Inositol Versus Glucophage in Terms of Glycemic Control Among Patients With Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Glycemic Control
研究概览
简要总结
This randomized controlled trial aims to compare the efficacy of Glucophage plus Myo-Inositol versus Glucophage alone in glycemic control among patients with gestational diabetes mellitus (GDM). The study will assess whether the addition of Myo-Inositol improves glycemic control and reduces insulin requirements in GDM patients. Participants will be randomized into two groups: one receiving Myo-Inositol in combination with Glucophage and the other receiving Glucophage alone. The primary outcome will be glycemic control as assessed by fasting and postprandial glucose levels. Secondary outcomes include insulin requirement and gestational age at initiation of insulin therapy.
详细描述
This prospective, single-center, randomized controlled trial is designed to evaluate the efficacy of Myo-Inositol supplementation in combination with Glucophage compared to Glucophage alone for glycemic control in women diagnosed with gestational diabetes mellitus (GDM). The trial will be conducted at SIMS/Services Hospital Lahore under the supervision of the University of Health Sciences Lahore.
Gestational diabetes mellitus (GDM) is a condition characterized by glucose intolerance that is first recognized during pregnancy, posing significant health risks for both the mother and fetus. Despite various treatment approaches, achieving optimal glycemic control remains a challenge. While Glucophage (Metformin) is widely used for managing GDM, Myo-Inositol has gained attention for its potential role in improving insulin sensitivity and reducing the need for additional pharmacological interventions.
Study Design and Methodology:
This study will enroll 90 participants aged 18-35 years with singleton pregnancies diagnosed with GDM between 22-32 weeks of gestation.
Participants will be randomly assigned to one of two intervention groups:
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 35 years and Singleton pregnancy
- •GDM diagnosed during pregnancy as per operational definition
- •22 to 32 weeks of gestation
- •No more than 35 days after GDM diagnosis
- •BMI of 18 to 29
- •Capacity for self-monitoring of blood glucose
排除标准
- •Patients with obesity BMI more than or equal to
- •Already taking insulin during this pregnancy or oral hypoglycemic agents
- •Patients taking long time corticosteroid treatment
- •Patients with history of pre-existing diabetes
- •Overt diabetes diagnosed during pregnancy, i.e. fasting plasma glucose ≥ 126 mg/dL (7 mmol/l) and/or 2-hour post OGTT plasma glucose value ≥ 200 mg/dL (11.1 mmol)
- •History of any bariatric surgery
- •Twin pregnanc
研究组 & 干预措施
Glucophage Alone
Intervention: Patients in this group will receive 500 mg Glucophage three times a day.
Monitoring: Blood glucose levels will be measured at baseline and after treatment.
干预措施: Glucophage (Other)
Glucophage Plus Myo-Inositol
Intervention: Patients in this group will receive 2 capsules of Myo-Inositol (2000 mg each) along with 500 mg Glucophage three times a day.
Monitoring: Blood glucose levels will be measured at baseline and after treatment.
干预措施: Glucophage (Other)
Glucophage Plus Myo-Inositol
Intervention: Patients in this group will receive 2 capsules of Myo-Inositol (2000 mg each) along with 500 mg Glucophage three times a day.
Monitoring: Blood glucose levels will be measured at baseline and after treatment.
干预措施: Myo-Inositol (Other)
结局指标
主要结局
Glycemic Control
时间窗: Baseline and up to 12 weeks
Glycemic control is defined as fasting glucose \<95 mg/dL and postprandial glucose \<120 mg/dL. Blood glucose levels will be recorded at follow-up visit
次要结局
未报告次要终点
研究者
Hifza Rasheed
Principal Investigator
University of Health Sciences Lahore