Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024583
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2001-09-21
Brief Title:
Prenatal Nutrition and Adult Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether maternal undernutrition in pregnancy is associated with differences between siblings for cardiovascular risk factors in adulthood
Detailed Description:
BACKGROUND
A variety of studies have reported associations between birth weight and other proxy measures of fetal nutrition and chronic disease risk in adulthood particularly metabolic diseases such as type 2 diabetes and cardiovascular disease CVD These findings have led to the theory of fetal programming of adult chronic disease This theory is highly provocative because it suggests that the prevention of many chronic diseases should start with the improvement of materno-fetal nutrition A mechanism for fetal programming of adult chronic disease risk however has not been identified In addition most epidemiological studies have been ecological and retrospective with poor identification of exposure dose and timing and control of confounders
DESIGN NARRATIVE
The cohort study determines whether famine exposure during the first second or third trimesters of gestation is associated with differences between sibs for CVD risk factors in adulthood specifically centralized obesity insulin resistance increased blood pressures dyslipidemia and diagnosed type 2 diabetes Using the data collected the investigators propose to 1 evaluate the key assumption that maternal undernutrition during pregnancy results in fetal programming of CVD risk factors 2 better identify the critical period during gestation in which this may occur and 3 determine the strength of the associations with chronic disease risk factors in adulthood
The study will utilize an innovative sib-pair design in which cases or probands exposed to fetal undernutrition during the Dutch Famine during 1944-45 will be matched to same-sex full siblings who were born in different years and not exposed The timing of births within the famine period will allow the investigators to classify proband exposure approximately by trimester of gestation Thus compared to most previous studies they will be better able to identify the critical period - early mid or late gestation - during which fetal programming effects are most likely to occur In addition the investigators will randomly select a sample of unexposed probands with birth dates in 1943 or 1947 immediately before and after the famine and matched siblings All exposed and unexposed probands will be ascertained from the prenatal and delivery records of three hospitals in the Western Netherlands where the famine was most intense These records include information on maternal and family medical history socioeconomic status pregnancy characteristics blood pressure weight gain etc and birth outcomes including anthropometry and gestational age Siblings will be identified using national Population Registers Bevolkings registers and hospital prenatal and delivery records will be obtained
In addition to collecting information from perinatal hospital and registry records all subjects will undergo a home interview and clinical examination The interview will collect information on sociodemographic characteristics economic status health history including obstetric history current health and medical treatment and health behaviors including physical activity The clinical examine will include a fasting blood draw for lipid glucose and insulin concentrations and a glucose tolerance test with additional blood draws at 30 and 120 minutes post-glucose load Blood will also be stored for future DNA isolation and assay of genetic polymorphisms that could influence associations among the study variables Anthropometry will include height weight waist circumference and abdominal sagital diameter A food frequency questionnaire will also be administered during either the interview or examination phase
An innovative part of the study will be measurements of hand morphology specifically fingertip ridge-count differences and digit-lengths These characteristics are established by the 19th week of gestation and are fixed thereafter throughout the lifetime There is some evidence that the development of these characteristics prior to 19 weeks of gestation may be influenced by environmental factors including materno-fetal nutrition The investigators will test the hypothesis that these finger and hand characteristics are markers of undernutrition during the first half of pregnancy and predict other adult CVD risk factors
A variety of studies have reported associations between birth weight and other proxy measures of fetal nutrition and chronic disease risk in adulthood particularly metabolic diseases such as type 2 diabetes and cardiovascular disease CVD These findings have led to the theory of fetal programming of adult chronic disease This theory is highly provocative because it suggests that the prevention of many chronic diseases should start with the improvement of materno-fetal nutrition A mechanism for fetal programming of adult chronic disease risk however has not been identified In addition most epidemiological studies have been ecological and retrospective with poor identification of exposure dose and timing and control of confounders
DESIGN NARRATIVE
The cohort study determines whether famine exposure during the first second or third trimesters of gestation is associated with differences between sibs for CVD risk factors in adulthood specifically centralized obesity insulin resistance increased blood pressures dyslipidemia and diagnosed type 2 diabetes Using the data collected the investigators propose to 1 evaluate the key assumption that maternal undernutrition during pregnancy results in fetal programming of CVD risk factors 2 better identify the critical period during gestation in which this may occur and 3 determine the strength of the associations with chronic disease risk factors in adulthood
The study will utilize an innovative sib-pair design in which cases or probands exposed to fetal undernutrition during the Dutch Famine during 1944-45 will be matched to same-sex full siblings who were born in different years and not exposed The timing of births within the famine period will allow the investigators to classify proband exposure approximately by trimester of gestation Thus compared to most previous studies they will be better able to identify the critical period - early mid or late gestation - during which fetal programming effects are most likely to occur In addition the investigators will randomly select a sample of unexposed probands with birth dates in 1943 or 1947 immediately before and after the famine and matched siblings All exposed and unexposed probands will be ascertained from the prenatal and delivery records of three hospitals in the Western Netherlands where the famine was most intense These records include information on maternal and family medical history socioeconomic status pregnancy characteristics blood pressure weight gain etc and birth outcomes including anthropometry and gestational age Siblings will be identified using national Population Registers Bevolkings registers and hospital prenatal and delivery records will be obtained
In addition to collecting information from perinatal hospital and registry records all subjects will undergo a home interview and clinical examination The interview will collect information on sociodemographic characteristics economic status health history including obstetric history current health and medical treatment and health behaviors including physical activity The clinical examine will include a fasting blood draw for lipid glucose and insulin concentrations and a glucose tolerance test with additional blood draws at 30 and 120 minutes post-glucose load Blood will also be stored for future DNA isolation and assay of genetic polymorphisms that could influence associations among the study variables Anthropometry will include height weight waist circumference and abdominal sagital diameter A food frequency questionnaire will also be administered during either the interview or examination phase
An innovative part of the study will be measurements of hand morphology specifically fingertip ridge-count differences and digit-lengths These characteristics are established by the 19th week of gestation and are fixed thereafter throughout the lifetime There is some evidence that the development of these characteristics prior to 19 weeks of gestation may be influenced by environmental factors including materno-fetal nutrition The investigators will test the hypothesis that these finger and hand characteristics are markers of undernutrition during the first half of pregnancy and predict other adult CVD risk factors
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL067914 | NIH | None | httpsreporternihgovquickSearchR01HL067914 |