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

November 20, 2024 updated by: Olga Sanz, Fundacion Miguel Servet

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain
        • Recruiting
        • Fundación Miguel Servet/Navarrabiomed
        • Contact:
        • Contact:
          • Teresa Esther Santa Cruz, MD
        • Contact:
          • Cristina Sarasqueta, MD, PhD
        • Contact:
          • Olga Sanz Asín, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance exercise
Other: Resistance exercise

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.

.
No Intervention: Control Group
Standard control and usual recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24-28 gestational weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight gain and excessive body weight gain
Time Frame: From baseline visit to the third trimester visit
Determined by IOM (Institute of Medicine) guideline
From baseline visit to the third trimester visit
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
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Miguel Servet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI_2022/126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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