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Cardiovascular DiseasesNCT00024583

Prenatal Nutrition and Adult Disease

An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine whether maternal undernutrition in pregnancy is associated with differences between siblings for cardiovascular risk factors in adulthood. Read more about this study

Who is it for?
Ages 55 to 60 years
How many people
Not given
Where
No sites listed yet
Study dates
Sep 2001to Aug 2006
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

No eligibility criteria

About this study

To determine whether maternal undernutrition in pregnancy is associated with differences between siblings for cardiovascular risk factors in adulthood.

Read the 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.

Medical subject headings
Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2, Insulin Resistance, Obesity, Hypertension

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2001 (estimated)
  2. Study startSep 2001
  3. Primary completionAug 2006
  4. Study completionAug 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00024583
Sponsor's protocol ID
984
Other IDs
R01HL067914
Status last verified
Jan 2008
First submitted
21 Sep 2001
Last updated
18 Feb 2016
Results posted
No

Publications

  • Stein AD, Zybert PA, Lumey LH. Acute undernutrition is not associated with excess of females at birth in humans: the Dutch hunger winter. Proc Biol Sci. 2004 May 7;271 Suppl 4(Suppl 4):S138-41. doi: 10.1098/rsbl.2003.0123.

    PubMed 15252965
  • Stein AD, Zybert PA, van de Bor M, Lumey LH. Intrauterine famine exposure and body proportions at birth: the Dutch Hunger Winter. Int J Epidemiol. 2004 Aug;33(4):831-6. doi: 10.1093/ije/dyh083. Epub 2004 May 27.

    PubMed 15166208

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00024583, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.

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