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

Primary Purpose

Diabetes, Gestational

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Resistance exercise
Sponsored by
Fundacion Miguel Servet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes, Gestational focused on measuring Exercise, Weight gain, Pregnant, Obese, Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fundación Miguel Servet/NavarrabiomedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resistance exercise

Control Group

Arm Description

Standard control and usual recommendations.

Outcomes

Primary Outcome Measures

Gestational diabetes
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

Weight gain and excessive body weight gain
Determined by IOM (Institute of Medicine) guideline
Maternal and fetal pregnancy outcomes
Newborn weight, preterm deliveries, Apgar score and pH of umbilical cord, duration of labour and delivery mode

Full Information

First Posted
April 13, 2023
Last Updated
April 24, 2023
Sponsor
Fundacion Miguel Servet
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1. Study Identification

Unique Protocol Identification Number
NCT05840497
Brief Title
Effect of Strength-resistance Exercise in the Reduction of Gestational Diabetes in Pregnant Women With Overweight or Obesity
Official Title
Efecto Del Ejercicio de Fuerza-resistencia en la disminución de la Diabetes Gestacional en Gestantes Con Sobrepeso u Obesidad
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Miguel Servet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational
Keywords
Exercise, Weight gain, Pregnant, Obese, Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance exercise
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard control and usual recommendations.
Intervention Type
Other
Intervention Name(s)
Resistance exercise
Intervention Description
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 Outcome Measure Information:
Title
Gestational diabetes
Description
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).
Time Frame
24-28 gestational weeks
Secondary Outcome Measure Information:
Title
Weight gain and excessive body weight gain
Description
Determined by IOM (Institute of Medicine) guideline
Time Frame
From baseline visit to the third trimester visit
Title
Maternal and fetal pregnancy outcomes
Description
Newborn weight, preterm deliveries, Apgar score and pH of umbilical cord, duration of labour and delivery mode
Time Frame
At birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Santa Cruz Sarasqueta
Phone
689203204
Email
te.santa.cruz@navarra.es
Facility Information:
Facility Name
Fundación Miguel Servet/Navarrabiomed
City
Pamplona
State/Province
Navarra
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Santa Cruz Sarasqueta
Email
te.santa.cruz@navarra.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17650297
Citation
Bhattacharya S, Campbell DM, Liston WA, Bhattacharya S. Effect of Body Mass Index on pregnancy outcomes in nulliparous women delivering singleton babies. BMC Public Health. 2007 Jul 24;7:168. doi: 10.1186/1471-2458-7-168.
Results Reference
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PubMed Identifier
35282280
Citation
Xu MY, Guo YJ, Zhang LJ, Lu QB. Effect of individualized weight management intervention on excessive gestational weight gain and perinatal outcomes: a randomized controlled trial. PeerJ. 2022 Mar 8;10:e13067. doi: 10.7717/peerj.13067. eCollection 2022.
Results Reference
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PubMed Identifier
21532964
Citation
Roberts JM, Bodnar LM, Patrick TE, Powers RW. The Role of Obesity in Preeclampsia. Pregnancy Hypertens. 2011 Jan 1;1(1):6-16. doi: 10.1016/j.preghy.2010.10.013.
Results Reference
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PubMed Identifier
26003406
Citation
Domingues MR, Bassani DG, da Silva SG, Coll Cde V, da Silva BG, Hallal PC. Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial. Trials. 2015 May 24;16:227. doi: 10.1186/s13063-015-0749-3.
Results Reference
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PubMed Identifier
33459493
Citation
Fair F, Soltani H. A meta-review of systematic reviews of lifestyle interventions for reducing gestational weight gain in women with overweight or obesity. Obes Rev. 2021 May;22(5):e13199. doi: 10.1111/obr.13199. Epub 2021 Jan 18.
Results Reference
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PubMed Identifier
28029178
Citation
Magro-Malosso ER, Saccone G, Di Mascio D, Di Tommaso M, Berghella V. Exercise during pregnancy and risk of preterm birth in overweight and obese women: a systematic review and meta-analysis of randomized controlled trials. Acta Obstet Gynecol Scand. 2017 Mar;96(3):263-273. doi: 10.1111/aogs.13087.
Results Reference
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PubMed Identifier
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Citation
Petrov Fieril K, Glantz A, Fagevik Olsen M. The efficacy of moderate-to-vigorous resistance exercise during pregnancy: a randomized controlled trial. Acta Obstet Gynecol Scand. 2015 Jan;94(1):35-42. doi: 10.1111/aogs.12525. Epub 2014 Nov 13.
Results Reference
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PubMed Identifier
19608151
Citation
Barakat R, Ruiz JR, Stirling JR, Zakynthinaki M, Lucia A. Type of delivery is not affected by light resistance and toning exercise training during pregnancy: a randomized controlled trial. Am J Obstet Gynecol. 2009 Dec;201(6):590.e1-6. doi: 10.1016/j.ajog.2009.06.004. Epub 2009 Jul 15.
Results Reference
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PubMed Identifier
35383101
Citation
Xie Y, Zhao H, Zhao M, Huang H, Liu C, Huang F, Wu J. Effects of resistance exercise on blood glucose level and pregnancy outcome in patients with gestational diabetes mellitus: a randomized controlled trial. BMJ Open Diabetes Res Care. 2022 Apr;10(2):e002622. doi: 10.1136/bmjdrc-2021-002622.
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PubMed Identifier
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Citation
Wang C, Wei Y, Zhang X, Zhang Y, Xu Q, Sun Y, Su S, Zhang L, Liu C, Feng Y, Shou C, Guelfi KJ, Newnham JP, Yang H. A randomized clinical trial of exercise during pregnancy to prevent gestational diabetes mellitus and improve pregnancy outcome in overweight and obese pregnant women. Am J Obstet Gynecol. 2017 Apr;216(4):340-351. doi: 10.1016/j.ajog.2017.01.037. Epub 2017 Feb 1.
Results Reference
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Effect of Strength-resistance Exercise in the Reduction of Gestational Diabetes in Pregnant Women With Overweight or Obesity

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