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临床试验/NCT05840497
NCT05840497招募中不适用

Efecto Del Ejercicio De Fuerza-resistencia En La Disminución De La Diabetes Gestacional En Gestantes Con Sobrepeso U Obesidad

Fundacion Miguel Servet1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年3月1日最近更新:
适应症

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

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

发起方
Fundacion Miguel Servet
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Sanz

MD

Fundacion Miguel Servet

研究点 (1)

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