Efecto Del Ejercicio De Fuerza-resistencia En La Disminución De La Diabetes Gestacional En Gestantes Con Sobrepeso U Obesidad
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Gestational diabetes
研究概览
简要总结
The aim of this trial is to test the efficacy of regular resistance exercise in early pregnancy to prevent gestational diabetes mellitus in overweight/ obese pregnant women.
详细描述
The growing rate of obesity is a major public health problem in the West, where 28% of pregnant women are overweight and 11% are obese. Worldwide, 50% of pregnant women are obese or overweight.
One of the problems directly related to obesity is gestational diabetes. In fact, its prevalence is increasing as the prevalence of obesity increases, as well as other complications of pregnancy. The prevalence of gestational diabetes in our environment is 6-12%.
Compared with pregnant women with BMI <25 kg/m2, pregnancies among women with obesity are at increased risk of several adverse outcomes, including early pregnancy loss, congenital anomalies, stillbirth, pregnancy-associated hypertension, preterm birth and postterm, gestational diabetes mellitus, multiple gestation, cesarean delivery, and birth of a macrosome.
The consequences of obesity in pregnant women can be decreased through physical activity. This hypothesis is due to several mechanisms: reduction of blood pressure, improvement of the lipid profile, reduction of oxidative stress and the proinflammatory state.
In recent years, scientific societies have published new recommendations on physical exercise in pregnant women with clear guidelines. Even this, less than 15% of patients do the recommended exercise. Usually the recommended exercise is aerobic and in the group of obese and overweight patients this type of exercise requires more effort and time, with the consequent worse adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI≥25 kg/m2
- •Singleton pregnancies
排除标准
- •Chronic hypertension
- •Pre-pregnancy DM (type I or 2 diabetes mellitus)
- •Cardiovascular disease
- •History of preterm delivery
结局指标
主要结局
Gestational diabetes
时间窗: 24-28 gestational weeks
Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with onset or first recognition during pregnancy: * O'Sullivan Test: if this is pathological; * SOG with 100 gr of glucose (GDM is diagnosed when 2 or more altered values: basal glycemia \>105 mg / dl, at 1 hour \>190 mg / dl, at 2h glycemia \>165 mg / dl, at 3h glycemia \>145 gr/dl).
次要结局
- Maternal and fetal pregnancy outcomes(At birth)
- Weight gain and excessive body weight gain(From baseline visit to the third trimester visit)
研究者
Olga Sanz
MD
Fundacion Miguel Servet
