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Clinical Trials/NCT05798494
NCT05798494
Recruiting
Not Applicable

PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus

Ulla Kampmann Opstrup1 site in 1 country140 target enrollmentStarted: June 1, 2023Last updated:
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ConditionsOverweight and ObesityWeight LossPregnancy RelatedChild Nutrition SciencesBody Composition

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Ulla Kampmann Opstrup
Enrollment
140
Locations
1
Primary Endpoint
Neonatal fat mass
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The study is a single site parallel randomized controlled study. The study will be assessing the effect of a 10% pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant and overweight or obese (BMI 27-44.9 kg/m^2). The couples in intervention group will receive dietitian counseling and participate in physical activity sessions to attain the 10% weight loss. The overall objective is to test whether a comprehensive pre-conceptional parental weight loss intervention effectively reduces the risk of offspring overweight, and adiposity and its complications compared to a control group.

Detailed Description

The study is a single site parallel randomized controlled study. The study will be assessing the effect of a pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant (recruited at gestational age 18-36), overweight or obese (BMI 27-44.9 kg/m^2), between 18-38 years and planning an additional pregnancy within the following 3 years.

The investigators will recruit a total of 140 healthy pregnant couples who will be randomized 1:1 to either intervention or control, stratified according to maternal pre-pregnancy BMI and previous or present diagnosis of gestational diabetes.

The couples in intervention group will receive dietary counseling by a dietitian from 3 months post-partum of the 1st child until birth of the 2nd child. The goal is to achieve a healthy lifestyle and a moderate weight loss of 10% according to pre-pregnancy weight during the first year. Hereafter, the couples will be guided in weight maintenance until pregnancy of the second child. During pregnancy the goal is to achieve a healthy weight gain. Couples in intervention group will also participate in physical activity sessions every 2nd week and advised to walk with moderate intensity at least 2-4 times a week for at least half an hour.

The overall objective is to test whether a comprehensive pre-conceptional parental weight loss intervention effectively reduces the risk of offspring overweight, and adiposity and its complications compared to a control group. The 1st baby born before intervention is started will be the "index child" and the metabolic and anthropometric parameters of the 1st child will be compared to parameters of the second child to assess the effect of the parent's healthy lifestyle between the two pregnancies.

The investigators hypothesize that parental weight loss intervention, initiated before conception, will facilitate lower parental insulin resistance, inflammation, body weight and adiposity, incretin responses and energy expenditure compared to usual care. For the offspring the investigators hypothesize that the intervention will reduce adverse pregnancy outcomes with a short-term reduction in the risk of being born large for gestational age with excessive fat mass and a long-term reduction in the risk of developing overweight or obesity as a consequence of both social (family approach) and biological (epigenetic modifications) pathways.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 38 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Paternal pre-pregnancy BMI 18.5-44.9 kg/m\^2
  • •Paternal age range 18-55 years
  • •Parental Inclusion Criteria:
  • •Couples (male and female)
  • •Planning pregnancy within 3 years
  • •Provided voluntary informed consent
  • •Danish or English speaking
  • •Intention to permit the planned offspring to participate in the follow-up study
  • •Able to store biological samples from the offspring at home in the freezer in a box given by the study personnel

Exclusion Criteria

  • •Diabetes mellitus (Type 1 or 2)
  • •Previous or present eating disorder
  • •Allergy towards ingredients in the very low calorie diet products
  • •Severe heart, liver or kidney disease
  • •Conception by in vitro fertilization
  • •Any medical condition or concomitant medication as judged by the medical responsible
  • •Adherence to vegan diets or other diets interfering with the dietary guidelines in the study
  • •Participation in other clinical trial that can affect the results of the current study
  • •Engagement in elite sports or similar strenuous exercise ≥5 h/week at inclusion
  • •Blood donation or transfusion within the past month before screening

Outcomes

Primary Outcomes

Neonatal fat mass

Time Frame: Collected within the first week of birth (strived <48 hours)

Offspring's neonatal fat mass (grams) assessed by air displacement plethysmography (Pea POD)

Difference in epigenetic changes in child 1 and 2

Time Frame: Assessed at birth

Cord blood from offspring will be collected at birth and stored at -80 °C until use. At the Department of Molecular Medicine AUH genomic DNA will be extracted from peripheral blood using standard methods e.g., QIAmp® Mini Kit (Qiagen, Germany). 1 μg of genomic DNA will be bisulfide converted using Illumina iScan (platform). The methylation level will be measured using Infinium MethylationEPIC DNA Analysis BeadChip (Array type) at Eurofins Genomics AS (Denmark) or similar methods. The stated required sample size (140 couples) is calculated based on the neonatal fat mass. As no other studies have performed methylation analysis using WGBS in similar cohorts, precise power calculations on epigenetic changes are impractical. However, since the EPICOM study found differentially methylated regions in only 20 cases and 20 controls using Illumina's 450K methylation assay, the power to elucidate epigenetic changes is considered sufficient in the planned study.

Secondary Outcomes

  • Adult Oral Glucose Tolerance Test (OGTT) during pregnancy (only female)(Collected in GA28 of 1st and 2nd pregnancy (performed after risk score at gestational age~20 and ~28 or only ~28))
  • Obstetric - pregnancy complications(Collected at gestational age (GA) 34-36 and after birth of both offsprings)
  • Obstetrics - birth defects/abnormalities(Collected at birth of both offsprings)
  • Offspring growth - small for gestational age(Collected at birth of both offsprings)
  • Adult weight(Intervention: each visit throughout study (GA34-36 of 1st child to 18mo. after birth of 2nd child). Control: In GA34-36 in both pregnancies, at study visits (3, 12 and 24mo. pp) and follow up visits (3, 12 and 18 months pp of 2nd child))
  • Obstetrics outcome - length of gestational age(Assessed at birth of both offsprings)
  • Fetal and offspring growth - femur length(Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies,)
  • Offspring blood pressure(Collected 12 and 18 months after birth of both offsprings)
  • Adult medication use(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st. child)
  • Adult reproduction - Time to pregnancy(Registration of 2nd. pregnancy (up to tree years from birth of 1.st. child))
  • Adult glucose metabolism (OGTT)(Performed at study visits 3, 12 and 24 months pp of 1st. child)
  • Placenta - weight (gram)(Collected at birth of both offsprings)
  • Obstetric - delivery mode(Collected at birth of both offsprings)
  • Obstetric - obstetrics complications(Collected at birth of both offsprings)
  • Fetal and offspring growth - body weight(Collected from medical record during pregnancy, measured in gestational age (GA) GA34-GA36 via ultrasound in both pregnancies, at birth and 3, 12 and 18 months after birth of both offsprings)
  • Fetal and offspring growth - length(Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies, and measured at birth and 3, 12 and 18 months after birth of both offsprings)
  • Fetal and offspring growth - crown circumference(Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies)
  • Offspring growth - weight for gestational age(Collected at birth and 3, 12 and 18 months after birth of both offsprings)
  • Offspring growth(Collected at birth and 3, 12 and 18 months after birth of offspring.)
  • Offspring growth - body composition by the POD system(Collected within the first week of birth and 3 months post partum in both offsprings)
  • Offspring heart rate(Collected 12 and 18 months after birth of both offsprings)
  • Offspring growth - self-reported body weight(18 months after birth the study staff will make an annual follow-up phone call to the parents to collect information about the offspring's self-reported body weight until the offspring is 18 of age)
  • Adult blood pressure(Collected at GA34-36 in 1st pregnancy, study visits 3, 12 and 24 months pp. of 1st child, GA34-36 in 2nd pregnancy and 3 months pp after 2nd child)
  • Offspring medication use(Birth, after 3, 12, and 18 months after birth of both offsprings)
  • Neonatal morbidities(Collected at birth of both offsprings)
  • Fetal and offspring growth - abdominal circumference(Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies, and measured at birth and 3, 12 and 18 months after birth of both offsprings)
  • Fetal growth - fractional limb volume(Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies,)
  • Offspring growth - BMI z-score(Collected at birth and 3, 12 and 18 months after birth of both offsprings)
  • Offspring growth - large for gestational age(Collected at birth of both offsprings)
  • Offspring growth - self-reported height(18 months after birth the study staff will make an annual follow-up phone call to the parents to collect information about the offspring's self-reported body weight until the offspring is 18 of age)
  • Obstetric - medication use(Collected from initiation of labor until completed birth of both offsprings)
  • Obstetric - Neonatal unit admissions(Collected at birth and until 12 months after birth of both offsprings)
  • Offspring growth - apgar score(Collected at birth of offspring of both offsprings)
  • Adult Height(Collected in GA34-GA36 in index pregnancy)
  • Adult BMI(Collected in GA34-36 in 1st pregnancy, study visits 3, 12 and 24mo. pp after 1st child, GA34-36 in 2nd pregnancy and at follow up vist (3, 12 and 18mo. pp of 2nd child).)
  • Adult anthropometric(Intervention: each visit throughout study (GA34-36 of 1st child to 18mo. after birth of 2nd child). Control: In GA34-36 in both pregnancies, at study visits (3, 12 and 24mo. pp) and follow up visits (3, 12 and 18 months pp of 2nd child))
  • Adult bone markers by DEXA scan - bone mineral content(Collected at study visits 3, 12 and 24 months pp. of 1st child)
  • Adult resting metabolic rate(Collected at study visit 3, 12, and 24 months pp after 1st child.)
  • VO2-max adult - cardiorespiratory fitness(Collected at study visit 3, 12 and 24 months pp after birth of 1st child)
  • Cardiac function offspring - TAPSE and RV fractional area change(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cardiac function offspring - Diastolic function, left ventricular E/A-ratio(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cardiac function offspring - Diastolic function, tissue velocities (E', A', S')(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cardiac function offspring - Diastolic function, strain(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cardiac function offspring - Pulmonary artery acceleration time(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cord blood - pH(Collected at birth)
  • Adult heart rate(Collected at GA34-36 in 1st pregnancy, study visits 3, 12 and 24 months pp. of 1st child, GA34-36 in 2nd pregnancy and 3 months pp after 2nd child)
  • Cardiac function offspring - Left ventricular and right ventricular morphology(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cardiac function offspring - Systolic function, strain(Collected at birth and at 12 months follow up visit after birth of each child)
  • Adult bone markers by DEXA scan - bone mineral density(Collected at study visits 3, 12 and 24 months pp. of 1st child)
  • Adult blood sample - CD163(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - eGFR(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Ferritin(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Triglyceride(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Total Cholesterol(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - vitamin B12(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult resting respiratory quotient + substrate(Collected at study visit 3, 12, and 24 months pp after 1st child.)
  • Cardiac function offspring - left centricular ejection fraction(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cardiac function offspring - fractional shortening(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cardiac function offspring - Systolic function, strain rate(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cardiac function offspring - Persistent ductus arteriosus (PDA)(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cord blood - Telomore length(Collected at birth of both offsprings)
  • Adult body composition by DEXA scan(Collected at study visits 3, 12 and 24 months pp. of 1st child)
  • Adult blood sample - C-reaktivt protein (CRP)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Bilirubin(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - vitamin D3(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Cardiac function offspring - Pulmonary artery pressure(Collected at birth and at 12 months follow up visit after birth of each child)
  • Cord blood - Epigenetics(Collected at birth of both offsprings)
  • Adult blood sample - Kreatinin(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Basisk fosfatase (BASP)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - platelets(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Cholesterol HDL(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Cholesterol LDL(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Fibroblast growth factor 21 (FGF-21)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Cardiac function offspring - Overall cardiac function(Collected at birth and at 12 months follow up visit after birth of each child)
  • Adult bone markers by DEXA scan - bone area(Collected at study visits 3, 12 and 24 months pp. of 1st child)
  • Adult blood sample - HbA1c(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Alanintransaminase (ALAT)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Gamma-GT (GGT)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - c-peptide(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Insulin-like Growth Factor-1 (IGF-1)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - glucose(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Hemoglobin(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Leukocytter(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Insulin-like growth factor-binding protein-3 (IGFBP-3)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Ghrelin(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Interleukin 6 (IL-10)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Interleukin-1 alpha (IL-1 alpha)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Tumor Necrosis Factor alfa (TNF-α)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Insulin-like growth factor-binding protein-1 (IGFBP-1)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Leptin(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Adiponectin(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Free fatty Acids (FFA)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Interleukin 6 (IL-6)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Offspring blood sample - insulin(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - IGFBP-3(Collected 12 months after birth in both offsprings)
  • Cord blood -FFA(Collected at birth of both offspring)
  • Adult blood sample - Growth Hormone (GH)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult blood sample - Interferon gamma (IFN-γ)(Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child)
  • Adult female blood sample - Progesterone(Collected at GA34-GA36 in both pregnancies)
  • Adult female blood sample - sex hormone binding globulin (SHBG)(Collected at GA34-GA36 in both pregnancies)
  • Adult female blood sample -Estradiol(Collected at GA34-GA36 in both pregnancies)
  • Offspring blood sample - glucose(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - cTroponin I (cTnI)(Collected 12 months after birth in both offsprings)
  • Cord blood - c-peptide(Collected at birth of both offspring)
  • Cord blood -IGFBP-1(Collected at birth of both offspring)
  • Cord blood -Ferritin(Collected at birth of both offspring)
  • Cord blood -IGFBP-3(Collected at birth of both offspring)
  • Adult female blood sample - Humant choriogonadotropin (hCG)(Collected at GA34-GA36 in both pregnancies)
  • Offspring blood sample - c-peptide(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - HgbA1c(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - Adiponectin(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - FFA(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - Growth Hormone (GH)(Collected 12 months after birth in both offsprings)
  • Cord blood -cTnI(Collected at birth of both offspring)
  • Cord blood -CRP(Collected at birth of both offspring)
  • Adult female blood sample - Proinsulin C-peptide(Collected at GA34-GA36 in both pregnancies)
  • Offspring blood sample - Ferritin(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - CRP(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - Cholesterol HDL(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - Total Cholesterol(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - Leptin(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - BNP(Collected 12 months after birth in both offsprings)
  • Cord blood -BNP(Collected at birth of both offspring)
  • Adult female blood sample - Prolactin(Collected at GA34-GA36 in both pregnancies)
  • Adult blood sample -Cortisol(Collected at GA34-GA36 in both pregnancies)
  • Offspring blood sample - IGF-1(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - IGFBP-1(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - CD163(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - Hgb(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - Triglyceride(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - Cholesterol LDL(Collected 12 months after birth in both offsprings)
  • Offspring blood sample - FGF-21(Collected 12 months after birth in both offsprings)
  • Cord blood -Insulin(Collected at birth of both offspring)
  • Cord blood -IGF-1(Collected at birth of both offspring)
  • Cord blood -FGF21(Collected at birth of both offspring)
  • Cord blood -Leptin(Collected at birth of both offspring)
  • Cord blood - HbA1c(Collected at birth of both offspring)
  • Cord blood - IL-10(Collected at birth of both offspring)
  • Cord blood -CD163(Collected at birth of both offspring)
  • Cord blood - IL-1 alpha(Collected at birth of both offspring)
  • Cord blood -IFN- gamma(Collected at birth of both offspring)
  • Cord blood -Adiponectin(Collected at birth of both offspring)
  • Cord blood - IL-6(Collected at birth of both offspring)
  • Cord blood -TNF- alpha(Collected at birth of both offspring)
  • Cord blood - Vitamin D3(Collected at birth of both offspring)

Investigators

Sponsor
Ulla Kampmann Opstrup
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ulla Kampmann Opstrup

Associate professor

Aarhus University Hospital

Study Sites (1)

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