Effect of Strength-resistance Exercise in the Reduction of Gestational Diabetes in Pregnant Women with Overweight or Obesity
- Conditions
- Diabetes, Gestational
- Interventions
- Other: Resistance exercise
- Registration Number
- NCT05840497
- Lead Sponsor
- Fundacion Miguel Servet
- Brief Summary
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.
- Detailed Description
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.
In non-pregnant patients, exercise has been shown to be related to a decrease in cardiovascular risk and DM2. However, in pregnant patients, a meta-review of systematic reviews has shown that although lifestyle interventions decrease weight gain, they do not have a clear benefit in terms of maternal-fetal outcomes.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- BMI≥25 kg/m2
- Singleton pregnancies
- Chronic hypertension
- Pre-pregnancy DM (type I or 2 diabetes mellitus)
- Cardiovascular disease
- History of preterm delivery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Resistance exercise Resistance exercise -
- Primary Outcome Measures
Name Time Method Gestational diabetes 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).
- Secondary Outcome Measures
Name Time Method Maternal and fetal pregnancy outcomes At birth Newborn weight, preterm deliveries, Apgar score and pH of umbilical cord, duration of labour and delivery mode
Weight gain and excessive body weight gain From baseline visit to the third trimester visit Determined by IOM (Institute of Medicine) guideline
Trial Locations
- Locations (1)
Fundación Miguel Servet/Navarrabiomed
🇪🇸Pamplona, Navarra, Spain