Very Low Carbohydrate Dietary Intervention in Gestational Diabetes Mellitus: Effect on Glycemic, Metabolic, Glycated and Inflammatory Marker: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Asses change in Adiponectin
研究概览
简要总结
Uncontrolled Gestational Diabetes Mellitus may leads to maternal and fetal complications. These complications can be avoided by adopting the dietary modifications along with medications. Previous studies suggested that consumption of low Carbohydrate diet improves Gestational Diabetes and related complications. Therefore, this study aims to investigate the effect of very low carbohydrate dietary intervention on glycemic, glycemic, metabolic, glycated and inflammatory markers.
详细描述
This will be randomized controlled trial of 80-100 Gestational diabetic women of second trimester to investigate the effect of very low carbohydrate dietary intervention on glycemic, metabolic, glycated and inflammatory markers.
Subjects will be recruited from ob/gyn outpatient of different hospitals. Eligible subjects will be enrolled in the study and will be allocated into two groups. One will be intervention and other will be control group. At baseline fasting blood samples from both group will be taken and will be analyzed for different biomarkers. Thereafter, the experimental group will be counseled about their modified diet (very low carbohydrate diet <10%,40-50% protein and lipid in diet). Control group will be allowed to continue their routine diet counselled as part of their antenatal care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •2nd trimester women with GDM
- •Either taking or not taking oral hypoglycemic agent or insulin
排除标准
- •Previously known type 1 or type 2 Diabetic patients
- •Age less than 18 and above 40 years
- •Any other chronic disease
结局指标
主要结局
Asses change in Adiponectin
时间窗: Baseline after one month and two month
Carboxymethyl-lysine
时间窗: Baseline after one month and two month
Asses change in NFk
时间窗: Baseline after one month and two month
Asses change in Postprandial glucose
时间窗: Baseline after one month and two month
Asses change in Glycated hemoglobin A1c (HbA1c)
时间窗: Baseline after one month and two month
Asses change in Fasting blood glucose
时间窗: Baseline after one month and two month
Asses change in HOMA-IR
时间窗: Baseline after one month and two month
Asses change in Lean and fat body mass
时间窗: Baseline after one month and two month
Asses change in Fasting insulin
时间窗: Baseline after one month and two month
Asses change in C-reactive protein
时间窗: Baseline after one month and two month
次要结局
未报告次要终点
研究者
Bibi Hajira
Assistant Professor
Khyber Medical University Peshawar