DiabetesCHIPS-ChildNCT01545492
Testing the Developmental Origins Hypothesis
An observational study of Diabetes and Stroke, run by Children's & Women's Health Centre of British Columbia at 41 sites in 8 countries.
Trial summary
INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in pregnancy is better for the baby without… Read more about this study
- Who is it for?
- Any age
- How many people
- 626 participants
- Where
- 41 sitesin 8 countries
- Study dates
- Jan 2012to Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Only women participating in the CHIPS RCT and their children born after recruitment are eligible to participate in CHIPS-Child.
Who may be able to join
- All women participating in CHIPS and their children born after recruitment.
Who cannot join
- Women who have experienced the loss of their pregnancy or child after recruitment into CHIPS.
Trial locations and contacts
41 sites in 8 countries.
41 sites in 8 countries
Netherlands11 sites, 11 recruiting
- Recruiting
Academic Medical Center
Amsterdam
- Recruiting
OLVG
Amsterdam
- Recruiting
VU Medical Center
Amsterdam
- Recruiting
UMCG
Groningen
- Recruiting
Tergooiziekenhuizen
Hilversum
- Recruiting
MUMC Maastricht
Maastricht
- Recruiting
St Antonius Ziekenhuis
Nieuwegein
- Recruiting
Diakonessen Ziekenhuis
Utrecht
- Recruiting
UMCU
Utrecht
- Recruiting
Maxima Medical Centre
Veldhoven
- Recruiting
Isala Klinieken Zwolle
Zwolle
United Kingdom11 sites, 11 recruiting
- Recruiting
Birmingham Women's Hospital
Birmingham
- Recruiting
Bradford Royal Infirmary
Bradford
- Recruiting
Royal Lancaster Infirmary
Lancaster
- Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne
- Recruiting
Nottingham City Hospital
Nottingham
- Recruiting
Southport & Ormskirk Hospital
Ormskirk
- Recruiting
Derriford Hospital
Plymouth
- Recruiting
City Hospitals Sunderland NHS Foundation Trust
Sunderland
- Recruiting
Singleton Hospital
Swansea
- Recruiting
New Cross Hospital
Wolverhampton
- Recruiting
York District Hospital
York
Canada9 sites, 9 recruiting
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta
- Recruiting
IWK Health Centre
Halifax, Nova Scotia
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
Hopital Sainte-Justine
Montreal, Quebec
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan
- Recruiting
CHUS Fleurimont
Sherbrooke, Ontario
- Recruiting
Surrey Memorial Hospital: Jim Pttison Outpatient Care & Surgery Centre
Surrey, British Columbia
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
- Recruiting
BC Children & Women's Health Centre
Vancouver, British Columbia, V6H 3N1
Laura A Magee, MD FRCPC MSc
United States4 sites, 4 recruiting
- Recruiting
Copper University Hospital
Camden, New Jersey, 08103
- Recruiting
Norton Hospital Downtown & Suburban
Louisville, Kentucky, 40202
- Recruiting
Yale-New Haven Hospital
New Haven, Connecticut, 06510
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Australia2 sites, 2 recruiting
- Recruiting
Ipswich Hospital
Ipswich
- Recruiting
King Edward Memorial Hospital
Subiaco
Chile2 sites, 2 recruiting
- Recruiting
Hospital Base Osorno
Osorno
- Recruiting
Hospital Dr Sotero del Rio
Puente Alto
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital - Women's Clinic
Tartu
New Zealand1 site, 1 recruiting
- Recruiting
Christchurch Women's Hospital
Christchurch
About this study
Official title: CHIPS-Child:Testing the Developmental Origins Hypothesis
INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk.
CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference.
OBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.
Read the detailed description
INTRODUCTION: Growing evidence shows that reduced fetal growth rate is associated with adult cardiovascular risk markers (e.g., obesity) and disease, and evidence worldwide indicates that this relationship is independent of birthweight. The leading theory describes 'developmental programming' in utero leading to permanent alteration of the fetal genome. While those changes are adaptive in utero, they may be maladaptive postnatally.
OBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.
METHODS: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk.
CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference.
Sample size:. CHIPS will recruit 1028 women. We estimate that 80% of CHIPS centres will participate in CHIPS-Child, approximately 97% of babies will survive, and 90% of children will be followed to 12 m resulting in a sample size of 626. Power will be >80% to detect a between-group difference of ≥0.25 in 'change in z-score for weight' between birth and 12 m (2-sided alpha=0.05, SD 1).
- Keywords
- CHIPS, famine, reprogramming, developmental, blood, pressure, randomised, randomized, hypertension, anthropometry, measurement, genetics, epigenetics, methylation, cortisol, stress, DNA, growth, weight, length
- Medical subject headings
- Diabetes Mellitus, Stroke, Obesity, Hypertension, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tight | Children born to women in the CHIPS RCT randomized to "Tight" blood pressure control [target diastolic BP 85mmHg] | |
| Less Tight | Children born to women in the CHIPS RCT randomized to "Less Tight" [target diastolic BP 100mmHg]. |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in 'change in z score for weight' at 12 m(+/- 2m)
Between-group difference in early postnatal weight gain ('change in z score for weight') between birth and 12 m (p<0.05), 24m, 36m, 48m \& 60m.
Measured: birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m
Secondary outcomes (2)
hypothalamic pituitary adrenal axis function
Hair collected at 12m (+/-2m) of age will be analysed for hypothalamic pituitary adrenal axis function (hair cortisol for overall cortisol production).
Measured: average of 12m (+/-2m) of age
differences in DNA methylation
Buccal swab samples collected at 12m (+/-2m) of age will be assessed for between-groups differences in DNA methylation, using targeted (genes associated with growth, obesity, cardiovascular disease, and/or a developmental programming effect) and global (genome-wide microarray) methods.
Measured: average of 12 m (+/- 2m) of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 626 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's & Women's Health Centre of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Magee, Children's & Women's Health Centre of British Columbia
- Investigators
- Laura A Magee, MD, Principal investigator, BC Children & Women's Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545492
- Sponsor's protocol ID
- H08-00882CHIPS-Child
- Acronym
- CHIPS-Child
- Status last verified
- Mar 2012
- First submitted
- 24 Feb 2012
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wadhwa PD, Buss C, Entringer S, Swanson JM. Developmental origins of health and disease: brief history of the approach and current focus on epigenetic mechanisms. Semin Reprod Med. 2009 Sep;27(5):358-68. doi: 10.1055/s-0029-1237424. Epub 2009 Aug 26.
PubMed 19711246Waterland RA, Michels KB. Epigenetic epidemiology of the developmental origins hypothesis. Annu Rev Nutr. 2007;27:363-88. doi: 10.1146/annurev.nutr.27.061406.093705.
PubMed 17465856Gilbert EF, Varakis J, Opitz JM, ZuRhein GM, Ware R, Viseskul C, Kaveggia EG, Hartmann HA. Generalized gangliosidosis type II (juvenile GM1 gangliosidosis). A pathological, histochemical and ultrastructural study. Z Kinderheilkd. 1975 Sep 11;120(3):151-80. doi: 10.1007/BF00439006.
PubMed 126533Painter RC, Roseboom TJ, Bleker OP. Prenatal exposure to the Dutch famine and disease in later life: an overview. Reprod Toxicol. 2005 Sep-Oct;20(3):345-52. doi: 10.1016/j.reprotox.2005.04.005.
PubMed 15893910Tobi EW, Lumey LH, Talens RP, Kremer D, Putter H, Stein AD, Slagboom PE, Heijmans BT. DNA methylation differences after exposure to prenatal famine are common and timing- and sex-specific. Hum Mol Genet. 2009 Nov 1;18(21):4046-53. doi: 10.1093/hmg/ddp353. Epub 2009 Aug 4.
PubMed 19656776Silveira PP, Portella AK, Goldani MZ, Barbieri MA. Developmental origins of health and disease (DOHaD). J Pediatr (Rio J). 2007 Nov-Dec;83(6):494-504. doi: 10.2223/JPED.1728.
PubMed 18074050Cameron N, Demerath EW. Critical periods in human growth and their relationship to diseases of aging. Am J Phys Anthropol. 2002;Suppl 35:159-84. doi: 10.1002/ajpa.10183.
PubMed 12653312
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHIPS-Child:Testing the Developmental Origins Hypothesis
- ClinicalTrials.gov ID
- NCT01545492
- Acronym / sponsor ID
- CHIPS-Child / H08-00882CHIPS-Child
- Keywords
- CHIPS, famine, reprogramming, developmental, blood, pressure, randomised, randomized
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 626 participants (estimated)
- Lead sponsor
- Children's & Women's Health Centre of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk.
CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference.
OBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.
Detailed description
INTRODUCTION: Growing evidence shows that reduced fetal growth rate is associated with adult cardiovascular risk markers (e.g., obesity) and disease, and evidence worldwide indicates that this relationship is independent of birthweight. The leading theory describes 'developmental programming' in utero leading to permanent alteration of the fetal genome. While those changes are adaptive in utero, they may be maladaptive postnatally.
OBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.
METHODS: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk.
CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference.
Sample size:. CHIPS will recruit 1028 women. We estimate that 80% of CHIPS centres will participate in CHIPS-Child, approximately 97% of babies will survive, and 90% of children will be followed to 12 m resulting in a sample size of 626. Power will be >80% to detect a between-group difference of ≥0.25 in 'change in z-score for weight' between birth and 12 m (2-sided alpha=0.05, SD 1).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight | – | –Children born to women in the CHIPS RCT randomized to "Tight" blood pressure control [target diastolic BP 85mmHg] |
| Less Tight | – | –Children born to women in the CHIPS RCT randomized to "Less Tight" [target diastolic BP 100mmHg]. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Only women participating in the CHIPS RCT and their children born after recruitment are eligible to participate in CHIPS-Child.
Key inclusion criteria (1 listed)
- All women participating in CHIPS and their children born after recruitment.
Key exclusion criteria (1 listed)
- Women who have experienced the loss of their pregnancy or child after recruitment into CHIPS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
difference in 'change in z score for weight' at 12 m(+/- 2m)
Time frame: birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m
Between-group difference in early postnatal weight gain ('change in z score for weight') between birth and 12 m (p<0.05), 24m, 36m, 48m \& 60m.
2 secondary outcomes
hypothalamic pituitary adrenal axis function
Time frame: average of 12m (+/-2m) of age
differences in DNA methylation
Time frame: average of 12 m (+/- 2m) of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
- Background: PubMed 19711246Wadhwa PD, Buss C, Entringer S, Swanson JM. Developmental origins of health and disease: brief history of the approach and current focus on epigenetic mechanisms. Semin Reprod Med. 2009 Sep;27(5):358-68. doi: 10.1055/s-0029-1237424. Epub 2009 Aug 26.
- Background: PubMed 17465856Waterland RA, Michels KB. Epigenetic epidemiology of the developmental origins hypothesis. Annu Rev Nutr. 2007;27:363-88. doi: 10.1146/annurev.nutr.27.061406.093705.
- Background: PubMed 126533Gilbert EF, Varakis J, Opitz JM, ZuRhein GM, Ware R, Viseskul C, Kaveggia EG, Hartmann HA. Generalized gangliosidosis type II (juvenile GM1 gangliosidosis). A pathological, histochemical and ultrastructural study. Z Kinderheilkd. 1975 Sep 11;120(3):151-80. doi: 10.1007/BF00439006.
- Background: PubMed 15893910Painter RC, Roseboom TJ, Bleker OP. Prenatal exposure to the Dutch famine and disease in later life: an overview. Reprod Toxicol. 2005 Sep-Oct;20(3):345-52. doi: 10.1016/j.reprotox.2005.04.005.
- Background: PubMed 19656776Tobi EW, Lumey LH, Talens RP, Kremer D, Putter H, Stein AD, Slagboom PE, Heijmans BT. DNA methylation differences after exposure to prenatal famine are common and timing- and sex-specific. Hum Mol Genet. 2009 Nov 1;18(21):4046-53. doi: 10.1093/hmg/ddp353. Epub 2009 Aug 4.
- Background: PubMed 18074050Silveira PP, Portella AK, Goldani MZ, Barbieri MA. Developmental origins of health and disease (DOHaD). J Pediatr (Rio J). 2007 Nov-Dec;83(6):494-504. doi: 10.2223/JPED.1728.
- Background: PubMed 12653312Cameron N, Demerath EW. Critical periods in human growth and their relationship to diseases of aging. Am J Phys Anthropol. 2002;Suppl 35:159-84. doi: 10.1002/ajpa.10183.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A Magee, MD principal investigator
BC Children & Women's Health Centre
41 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Stroke, run by Children's & Women's Health Centre of British Columbia at 41 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Netherlands, United Kingdom, Canada, United States, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristal T Louie, MS (604.875.2424 ext. 5321, CHIPS-Child@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in 'change in z score for weight' at 12 m(+/- 2m) (time frame: birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01545492, which also lists 7 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 6 Mar 2012.