The Effect of TUBER Recommendations and the DASH Diet on Blood Parameters in Patients With Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in fasting blood glucose levels
研究概览
简要总结
The aim of this clinical trial was to examine the effects of the Turkish Nutrition Guide Recommendations Diet and the DASH Diet on blood sugar, blood pressure, and biochemical parameters in patients with gestational diabetes. The study hypotheses are as follows:
Hypothesis 1: The DASH diet reduces fasting blood glucose levels more in patients with gestational diabetes compared to a diet adapted to a healthy diet specific to Türkiye.
Hypothesis 1: The DASH diet reduces insulin levels more in patients with gestational diabetes compared to a diet adapted to a healthy diet specific to Turkey.
Hypothesis 1: The DASH diet reduces HbA1c levels more in patients with gestational diabetes compared to a diet adapted to a healthy diet specific to Türkiye.
Hypothesis 1: The Dash diet reduces 1st-hour postprandial glucose levels more significantly in women with gestational diabetes compared to a diet adapted to a healthy diet typical of Türkiye.
Participants:
After being diagnosed with gestational diabetes by a doctor using an OGTT test at 24-28 weeks, the researcher will complete a general information form during their first consultation with the dietitian. For four weeks, the dietitian will follow the diets created by the researcher based on their assigned diet group in a blinded manner. They will record their fasting and postprandial blood sugar levels in the morning, noon, evening, night, and during snacks, if they are taking them. They will keep a 24-hour food consumption record before meeting with the researcher weekly. Participants will have their biochemical parameters assessed at the beginning of the study and at the end of the fourth week.
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 (Participant)
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
- •Female participants aged 18 to 35 years
- •Singleton pregnancy
- •Clinical diagnosis of gestational diabetes mellitus (GDM)
- •Ability to use a glucometer
排除标准
- •Pre-gestational diabetes or impaired glucose tolerance (IGT)
- •Hypoglycemia
- •Receiving insulin therapy
- •Development of preeclampsia
- •Failure to adhere to the prescribed diet
- •Alcohol consumption
结局指标
主要结局
Change in fasting blood glucose levels
时间窗: Daily for 4 weeks
To monitor daily fasting blood glucose levels (mg/dL) using a glucometer throughout the 4-week intervention.
次要结局
- Change in 1-hour postprandial blood glucose levels(Daily for 4 weeks)
- Change in fasting insulin level(Baseline and Week 4)
- Change in daily energy and nutrient intake based on 24-Hour Food Consumption Record(Baseline and weekly over 4 weeks)
- Change in lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)(Baseline and Week 4)
- Change in iron-related parameters (iron, ferritin, total iron-binding capacity)(Baseline and Week 4)
- Change in vitamin and hematological markers (Vitamin D, folic acid, hemoglobin, hematocrit)(Baseline and Week 4)
- Change in HbA1c level(Baseline and Week 4)
研究者
Kardelen Kandemir
Research Asisstant (Dietitian)
Atlas University