Medical Nutrition Therapy in Gestational Diabetes Mellitus: Comparison of Different Number of Meals. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Preprandial ketonemia
研究概览
简要总结
Hypothesis: Patients with Gestational Diabetes Mellitus (GDM) have a high risk to develop complications during pregnancy, puerperium and in the newborn. At present there are not scientific evidences about the optimal distribution of meals in the medical nutrition therapy (MNT) and their relationship with glycemic control.
Aim: To explore and compare ketonemia and glycemic profile in patients with GDM that follow a MNT distributed in 6 or 3 meals. Besides, we want to explore the differences between both treatments in glucose dynamics.
Methods: The study design is a randomized, crossover and multicentric trial. A sample of 10 patients with GDM will be recruited in the Department of Endocrinology and Nutrition from both centres. In a randomized manner patients will follow the conventional treatment (a carbohydrate-controlled diet distributed in 6 meals: 3 main meals and 3 snacks) and the intervention treatment (a carbohydrate-controlled diet distributed in 3 meals: breakfast, lunch and dinner). They will be randomized to begin with one of the two treatments, and after two weeks they will be switched to the other treatment. Patients will wear a blinded continuous glucose monitoring device (iPro2-TM, Medtronic) during the entire study period.
Inclusion criteria:
- Women with GDM diagnosed in 24-28 weeks.
- Age 18-40 years.
- Pregnancy age of 28-32 weeks.
- Caucasian.
- Body mass index ≤ 35 Kg/m2.
Exclusion criteria:
- Unability to understand the dietary recommendations and/or to perform self-management of glycemia, ketonuria or ketonemia.
- A low adherence to MNT.
- Problems with written and/or oral communication.
- Presence of comorbidities other than obesity, hypertension and dyslipidemia.
- Insulin-need criteria within 3 first days of the beginning of the study (fasting glucose ≥90mg/dL, postprandial glucose 1-hour ≥140mg/dL).
Clinical and sociodemographic variables will be assessed. Dietary records and blood samples will be collected. Daily basal ketonuria and ketonemia before each meal will be assessed. Glycemic profile will be collected with a blind-sensor during the four weeks of the intervention study. Generalized linear model analysis will be performed. Statistical power will be 80% and significance level will be set at 0.05. Written informed consent will be collected from all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Glycemic profile will be collected with a blind-sensor during the study.
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
- •Women with GDM diagnosed in 24-28 weeks.
- •Age 18-40 years.
- •Pregnancy age of 28-32 weeks.
- •Caucasian.
- •Body mass index ≤ 35Kg/m
- •Firs-time mother.
排除标准
- •Disability to understand the dietary recommendations and/or to perform self-management of glycemia, ketonuria or ketonemia.
- •A low adherence to MNT.
- •Problems with write and oral communication.
- •Other comorbidities differed of obesity, hypertension and dyslipidemia.
- •Insulin criteria within 3 first days of study (fasting glucose ≥90mg/dL, postprandial glucose 1-hour ≥140mg/dL).
结局指标
主要结局
Preprandial ketonemia
时间窗: 4 weeks (2 weeks with the conventional treatment and 2 weeks with the intervention treatment)
Before the 3 main meals every day.
Glycemic profile below pregnancy target capillary blood glucose concentration
时间窗: 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment)
Self monitoring blood glucose levels: pre meals \< 90 mg/dL, 1 hour post meals \<140mg/dL
次要结局
- Newborn hypoglycemia(48 hours from delivery)
- Postpartum glucose tolerance of the mother(6 weeks after delivery)
- Area under the curve of interstitial glucose levels(Time Frame: 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment))
- Fetal Macrosomia(Through study completion, 4 weeks)
- Newborn body weight adjusted for gestational age (national standardized charts)(At delivery)
- Point-of-care glycated hemoglobin (HbA1c)(Every 2 weeks from the date of randomization until the last visit of the study)
研究者
Didac Mauricio
Head of Endocrinology and Nutrition
Germans Trias i Pujol Hospital