Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring

NCT02992106 | Completed

• 1 other identifier: EFFECTOR
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

The rising worldwide prevalence of obesity and its subsequently rising incidence of concommitant diseases as diabetes and cardiovascular events impose a defiant obstacle for the health care and associated health care costs of future generations. Obese pregnant women are a growing population of interest because their offspring is at risk for childhood obesity, an adverse metabolic and inflammatory profile and possible endothelial dysfunction. However, strong evidence is still lacking regarding the hypotheses on the early origin of these long-term health consequences. Consequently there is no comprehensive data available on the contribution of changing maternal weight through lifestyle interventions or bariatric surgery and an eventual adverse metabolic and endothelial programming of the offspring. The investigators of this study want to provide additional data on the body composition, metabolic and inflammatory state as well as endothelial function of children of obese pregnant women women and compare the outcome with children born from normal weight women. Furthermore, the investigators of this study will stratify the obese pregnant women into 3 groups: women who did not underwent an intervention, women who underwent a weight changing intervention during pregnancy e.g. diet or lifestyle intervention and women who underwent bariatric surgery before pregnancy. The overall aim of the study is to prove that in all the diverse groups of participating children, except the control group, there will be a certain grade of endothelial dysfunction, even if there was a normalization of weight, insulin sensitivity and inflammation before conception or delivery in the mother.

Conditions

Endothelial Dysfunction; Childhood Obesity

Keywords

Maternal Obesity; Endothelial Dysfunction; Childhood Obesity

Outcome Measures

Primary Outcomes (3)

• Reactive Hyperemia Index (EndoPAT)

  Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function

  Through study completion, average of 18 months

• Albumin to creatinin ratio in urine

  Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction

  Through study completion, average of 18 months

• Peak response after occlusion (EndoPAT)

  Determination of the peak response using 30s average of amplitude intervals./ In children considered as an important measurement regarding assessment of the endothelial cell function

  Through study completion, average of 18 months

Secondary Outcomes (5)

• BMI (kg/m²)

  Through study completion, average of 18 months

• Body fat percentage

  Through study completion, average of 18 months

• Insulin resistance

  Through study completion, average of 18 months

• Inflammatory state of the child (hs-CRP and IL-6)

  Through study completion, average of 18 months

• Lipid state in blood

  Through study completion, average of 18 months

Study Arms (4)

Normal weight during pregnancy

OTHER

Offspring of 156 women with a normal weight during their pregnancy recruited by Bogaerts et al, in 3 belgian hospitals. Results of maternal data published in 2013. Now the children will be recruited. This group wil function as a control group. All participating children will undergo the same examinations: * Parental questionnaires * Blood sample * Urine sample * Anthropometric measurements * Abdominal ultrasound (fat mass) * EndoPAT

Other: Parental questionnaires; Other: Blood sample; Other: Urine sample; Other: Anthropometric measurements; Other: Ultrasound; Other: EndoPAT; Other: Faces Pain Scale

Obese mothers without intervention

OTHER

This subgroup will be compiled of the offspring of women recruited in two different studies. First of all there is the offspring of 65 women from the cohort that was recruited by Guelinckx et al, data published in 2010. This population was recruited in the University hospital of Leuven as control group for women receiving lifestyle interventions during pregnancy. Secondly there are children of 63 women from the cohort of Bogaerts et al of 2013 that had a BMI \> 29 kg/m² during their singleton pregnancy. All participating children will undergo the same examinations: * Parental questionnaires * Blood sample * Urine sample * Anthropometric measurements * Abdominal ultrasound (fat mass) * EndoPAT

Other: Parental questionnaires; Other: Blood sample; Other: Urine sample; Other: Anthropometric measurements; Other: Ultrasound; Other: EndoPAT; Other: Faces Pain Scale

Obese mothers & lifestyle intervention

OTHER

This one will also be a composition of study subjects of two different study cohorts. Firstly there are children of about 100 Belgian women that were included in the DALI cohort, a European randomized controlled trial. All of them underwent a lifestyle intervention during pregnancy, concerning diet and/ or exercise. Secondly there is the offspring of the other subgroup of the cohort recruited by Guelinckx et al. 130 women were divided into 2 groups which underwent lifestyle interventions during pregnancy. All participating children will undergo the same examinations: * Parental questionnaires * Blood sample * Urine sample * Anthropometric measurements * Abdominal ultrasound (fat mass) * EndoPAT

Other: Parental questionnaires; Other: Blood sample; Other: Urine sample; Other: Anthropometric measurements; Other: Ultrasound; Other: EndoPAT; Other: Faces Pain Scale

History of bariatric surgery

OTHER

The PABAS cohort (Pregnancy After Bariatric Surgery) provides children of 49 women who underwent bariatric surgery before their singleton pregnancy. The women were included in five Flemish hospitals before 15 weeks of pregnancy. Furthermore we will recruit the offspring of 200 women that are recruited in the ongoing AURORA cohort (bAriatric sUrgery Registration in women Of Reproductive Age). Women in this cohort are recruited from the start of their process undergoing bariatric surgery and are followed until after their pregnancy. All participating children will undergo the same examinations: * Parental questionnaires * Blood sample * Urine sample * Anthropometric measurements * Abdominal ultrasound (fat mass) * EndoPAT

Other: Parental questionnaires; Other: Blood sample; Other: Urine sample; Other: Anthropometric measurements; Other: Ultrasound; Other: EndoPAT; Other: Faces Pain Scale

Interventions

Parental questionnaires OTHER

We will provide parents with questionnaires depending on the age of their children: * Children aged 0-6 years old: 1. Questionnaire on socio-demographic characteristics 2. Dutch Eating Behaviour Questionnaire 3. Food Frequency Questionnaire 4. Ages and Stages Questionnaire 5. Strengths and Difficulties Questionnaire 6. Questionnaire on developmental milestones 7. Questionnaire on behaviour * Children older than 6 years: 1. Questionnaire on socio-demographic characteristics 2. Dutch Eating Behaviour Questionnaire 3. Food Frequency Questionnaire 4. Pediatric Quality of Life Questionnaire 5. Children's Behaviour Questionnaire in Dutch 6. Questionnaire on developmental milestones 7. Developmental Coordination Disorder Questionnaire 8. Strengths and Difficulties Questionnaire

History of bariatric surgery; Normal weight during pregnancy; Obese mothers & lifestyle intervention; Obese mothers without intervention

Blood sample OTHER

We will determine the following biochemical parameters: glucose, insulin, total cholesterol, LDL, HDL, triglycerides, uric acid, IGF-1, adiponectin, leptin, hs-CRP, IL-6, TNF-α and ICAM-1.

History of bariatric surgery; Normal weight during pregnancy; Obese mothers & lifestyle intervention; Obese mothers without intervention

Urine sample OTHER

We will take a urine sample to evaluate the albumin to creatinin ratio.

History of bariatric surgery; Normal weight during pregnancy; Obese mothers & lifestyle intervention; Obese mothers without intervention

Anthropometric measurements OTHER

We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.

History of bariatric surgery; Normal weight during pregnancy; Obese mothers & lifestyle intervention; Obese mothers without intervention

Ultrasound OTHER

We will do an abdominal ultrasound to measure the abdominal fat accumulation

History of bariatric surgery; Normal weight during pregnancy; Obese mothers & lifestyle intervention; Obese mothers without intervention

EndoPAT OTHER

We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).

History of bariatric surgery; Normal weight during pregnancy; Obese mothers & lifestyle intervention; Obese mothers without intervention

Faces Pain Scale OTHER

After performing the measurements with the EndoPAT device, Harpender kalliper and ultrasound, the children will be asked to fill out a Faces Pain Scale, validated for children aged 4-16 years old and obtained for use from the International Association for the Study of Pain

History of bariatric surgery; Normal weight during pregnancy; Obese mothers & lifestyle intervention; Obese mothers without intervention

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children of women who previously participated in different cohort studies conducted in Flanders concerning maternal obesity are included after contacting the mothers again. During the initial clinical trials the mothers were informed of possible follow-up studies on their offspring.

You may not qualify if:

• For the peripheral pulse wave amplitude measurement we exclude children on growth hormone therapy.
• We postpone the examination for 2 weeks if there is an ongoing infection.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

University Hospital of Brussels

Brussels, 1090, Belgium

Location

Related Publications (1)

• Van De Maele K, Gies I, Devlieger R. Effect of bariatric surgery before pregnancy on the vascular function in the offspring: protocol of a cross-sectional follow-up study. BMJ Paediatr Open. 2019 Jan 31;3(1):e000405. doi: 10.1136/bmjpo-2018-000405. eCollection 2019.

  PMID: 30815589 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Pregnancy in Obesity

Interventions

Blood Specimen Collection; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Roland Devlieger, Professor

  Universitaire Ziekenhuizen KU Leuven

  STUDY DIRECTOR

• Inge Gies, Professor

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Karolien Van De Maele, M.D.

  Universitair Ziekenhuis Brussel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 14, 2016
• Study Start: May 10, 2017
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)