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NCT Number: NCT05840497

Effect of Strength-resistance Exercise in the Reduction of Gestational Diabetes in Pregnant Women with Overweight or Obesity

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Miguel Servet/Navarrabiomed

Pamplona, Navarre, Spain

Location status: Recruiting

Location contact

Cristina Sarasqueta, MD, PhD

CONTACT

Olga Sanz Asín, MD, PhD

CONTACT

Teresa Esther Santa Cruz, MD

CONTACT

Teresa Santa Cruz Sarasqueta

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI≥25 kg/m2
  • Singleton pregnancies

Exclusion criteria

  • Chronic hypertension
  • Pre-pregnancy DM (type I or 2 diabetes mellitus)
  • Cardiovascular disease
  • History of preterm delivery

Treatment and study plan

Resistance Exercise

Other

The intervention group will train 3 times per week (30 minutes with 15 min warm-up). The resistance exercise is described as the voluntary contraction of the skeletal muscle of a particular muscle group against some type of resistance, using light weights, elastic bands or the weight of the body itself.

Patients will be offered online sessions, they will receive a document with recommendations and a link to the videos with instructions.

.

Primary outcomes

  1. Gestational diabetes

    Time frame: 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 outcomes

  1. Weight gain and excessive body weight gain

    Time frame: From baseline visit to the third trimester visit

    Determined by IOM (Institute of Medicine) guideline

  2. Maternal and fetal pregnancy outcomes

    Time frame: At birth

    Newborn weight, preterm deliveries, Apgar score and pH of umbilical cord, duration of labour and delivery mode

Study contacts

Contact information is provided by the study sponsor or research team.

Teresa Santa Cruz Sarasqueta

CONTACT

[email protected]

689203204

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 3, 2023
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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