ObesityPREOBENCT01634464
Role of Nutrition and Maternal Genetics on the Programming of Development of Fetal Adipose Tissue
An observational study of Obesity and Diabetes, run by Universidad de Granada at 1 site in Spain.
Trial summary
In the PREOBE projects it is aimed to obtain genetic and biochemical biomarkers for the programming of obesity in early stages of life. This can be achieved by studying pregnant women with normal weight, overweight, obesity and gestational diabetes, and by analyzing how these conditions could impact on fetal growth… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2007to Jun 2013
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: A total of 350 pregnant women aged between 18 and 42, with singleton pregnancies, were recruited at 12 weeks of pregnancy at the Clinical University Hospital 'San Cecilio' and "Mother-Infant" Hospital in the city of Granada, Spain
Who may be able to join
- healthy pregnant women aged between 18 and 42
- singleton pregnancies
- pregnancy stage at recruitment: 12 weeks of pregnancy
Who cannot join
- Women who wish to participate in the study should not simultaneously participate in other research studies.
- Must be completely enclosed in one of the study of the groups without any possibility to be simultaneously incorporated on more groups of the study
- Mothers which are receiving any drug treatment, folate more than the 3rd first months, or DHA +/- vitamin supplements during pregnancy.
- Mothers affected by any disease other than those referred to the inclusion criteria, such hypertension or pre-eclampsia, foetal IUGR, mother infection during pregnancy, hypothyroidism / hyperthyroidism, hepatic diseases, renal disease,…
- Mothers following an extravagant diet or vegan diet.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Department of Pediatrics, School of Medicine, University of Granada
Granada, 18012
Cristina Campoy, Professor, MD, 0034 629308695, ccampoy@ugr.es
About this study
Official title: The Role of Nutrition and Maternal Genetics on the Programming of Development of Fetal Adipose Tissue. Search for Markers of the Obesity Risk in Early Stages of Life
In the PREOBE projects it is aimed to obtain genetic and biochemical biomarkers for the programming of obesity in early stages of life. This can be achieved by studying pregnant women with normal weight, overweight, obesity and gestational diabetes, and by analyzing how these conditions could impact on fetal growth and development; the risk of obesity in the offspring during the first 3 years of life will be also assessed (genetic polymorphisms of the most recognized genes related to obesity; gene expression of placental biomarkers indicators of early programming, polyunsaturated fatty acids, immunological and pro-inflammatory markers, analysis of endogenous and exogenous lipid peroxidation, allergies \& neurodevelopmental assessment...). Moreover, the interaction of pathological maternal conditions with confounder factors that could have a role in the proposed outcomes will be also studied (maternal and child dietary intake, medical history and socioeconomic \& environmental factors).
- Medical subject headings
- Obesity, Diabetes Mellitus
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 |
|---|---|---|
| Control group | women with 18.5 > BMI < 25 | |
| Pregnant women with overweight | BMI≥25 before the pregnancy | |
| Pregnant women with obesity | BMI≥30 before the pregnancy | |
| Pregnant women with gestational diabetes | Gestational diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term evidence of early human programming of obesity measured by nutritional biomarkers, and the offspring growth and development.
Measured: Participants will be followed for the duration of the study, an expected average of 6 years
Long-term evidence of early human programming of obesity measured by genetic biomarkers, and the offspring growth and development.
Measured: Participants will be followed for the duration of the study, an expected average of 6 years
Long-term evidence of early human programming of obesity measured biochemical perinatal biomarkers, and the offspring growth and development.
Measured: Participants will be followed for the duration of the study, an expected average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startMar 2007
- Primary completionOct 2010
- Study completionJun 2013 (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 ObesityStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Abbott, Scottish Government NuGO EU Project, University of Barcelona, ICTAN-CSIC - Madrid - Spain, Ludwig-Maximilians - University of Munich, University of Nottingham, University of Aberdeen, Andalusian Agency of Knowledge
- Responsible party
- Principal investigator, Cristina Campoy, Universidad de Granada
- Investigators
- Cristina Campoy, Professor, MD, Study director, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634464
- Sponsor's protocol ID
- P06-CTS-02341
- Other IDs
- 334602 Preobe Follow Up
- Acronym
- PREOBE
- Status last verified
- Jul 2012
- First submitted
- 19 Mar 2012
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Santacruz A, Collado MC, Garcia-Valdes L, Segura MT, Martin-Lagos JA, Anjos T, Marti-Romero M, Lopez RM, Florido J, Campoy C, Sanz Y. Gut microbiota composition is associated with body weight, weight gain and biochemical parameters in pregnant women. Br J Nutr. 2010 Jul;104(1):83-92. doi: 10.1017/S0007114510000176. Epub 2010 Mar 8.
PubMed 20205964Campoy C, Martin-Bautista E, Garcia-Valdes L, Florido J, Agil A, Lorente JA, Marcos A, Lopez-Sabater MC, Miranda-Leon T, Sanz Y, Molina-Font JA; grupo PREOBE. [Study of maternal nutrition and genetic on the foetal adiposity programming (The PREOBE study)]. Nutr Hosp. 2008 Nov-Dec;23(6):584-90. Spanish.
PubMed 19132267Cerdo T, Ruiz-Rodriguez A, Acuna I, Torres-Espinola FJ, Menchen-Marquez S, Gamiz F, Gallo M, Jehmlich N, Haange SB, von Bergen M, Campoy C, Suarez A. Infant gut microbiota contributes to cognitive performance in mice. Cell Host Microbe. 2023 Dec 13;31(12):1974-1988.e4. doi: 10.1016/j.chom.2023.11.004. Epub 2023 Dec 4.
PubMed 38052208Berglund SK, Garcia-Valdes L, Torres-Espinola FJ, Segura MT, Martinez-Zaldivar C, Aguilar MJ, Agil A, Lorente JA, Florido J, Padilla C, Altmae S, Marcos A, Lopez-Sabater MC, Campoy C; PREOBE team. Maternal, fetal and perinatal alterations associated with obesity, overweight and gestational diabetes: an observational cohort study (PREOBE). BMC Public Health. 2016 Mar 1;16:207. doi: 10.1186/s12889-016-2809-3.
PubMed 26931143Torres-Espinola FJ, Berglund SK, Garcia-Valdes LM, Segura MT, Jerez A, Campos D, Moreno-Torres R, Rueda R, Catena A, Perez-Garcia M, Campoy C; PREOBE team. Maternal Obesity, Overweight and Gestational Diabetes Affect the Offspring Neurodevelopment at 6 and 18 Months of Age--A Follow Up from the PREOBE Cohort. PLoS One. 2015 Jul 24;10(7):e0133010. doi: 10.1371/journal.pone.0133010. eCollection 2015.
PubMed 26208217Torres-Espinola FJ, Altmae S, Segura MT, Jerez A, Anjos T, Chisaguano M, Carmen Lopez-Sabater M, Entrala C, Alvarez JC, Agil A, Florido J, Catena A, Perez-Garcia M, Campoy C. Maternal PPARG Pro12Ala polymorphism is associated with infant's neurodevelopmental outcomes at 18 months of age. Early Hum Dev. 2015 Aug;91(8):457-62. doi: 10.1016/j.earlhumdev.2015.05.001. Epub 2015 May 26.
PubMed 26025336Uhl O, Demmelmair H, Segura MT, Florido J, Rueda R, Campoy C, Koletzko B. Effects of obesity and gestational diabetes mellitus on placental phospholipids. Diabetes Res Clin Pract. 2015 Aug;109(2):364-71. doi: 10.1016/j.diabres.2015.05.032. Epub 2015 May 16.
PubMed 26021978
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nutrition and Maternal Genetics on the Programming of Development of Fetal Adipose Tissue. Search for Markers of the Obesity Risk in Early Stages of Life
- ClinicalTrials.gov ID
- NCT01634464
- Acronym / sponsor ID
- PREOBE / P06-CTS-02341
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Abbott, Scottish Government NuGO EU Project, University of Barcelona, ICTAN-CSIC - Madrid - Spain, Ludwig-Maximilians - University of Munich, University of Nottingham, University of Aberdeen, Andalusian Agency of Knowledge
- Study start
- Mar 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 6 Jul 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.
In the PREOBE projects it is aimed to obtain genetic and biochemical biomarkers for the programming of obesity in early stages of life. This can be achieved by studying pregnant women with normal weight, overweight, obesity and gestational diabetes, and by analyzing how these conditions could impact on fetal growth and development; the risk of obesity in the offspring during the first 3 years of life will be also assessed (genetic polymorphisms of the most recognized genes related to obesity; gene expression of placental biomarkers indicators of early programming, polyunsaturated fatty acids, immunological and pro-inflammatory markers, analysis of endogenous and exogenous lipid peroxidation, allergies \& neurodevelopmental assessment...). Moreover, the interaction of pathological maternal conditions with confounder factors that could have a role in the proposed outcomes will be also studied (maternal and child dietary intake, medical history and socioeconomic \& environmental factors).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –women with 18.5 > BMI < 25 |
| Pregnant women with overweight | – | –BMI≥25 before the pregnancy |
| Pregnant women with obesity | – | –BMI≥30 before the pregnancy |
| Pregnant women with gestational diabetes | – | –Gestational diabetes |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 350 pregnant women aged between 18 and 42, with singleton pregnancies, were recruited at 12 weeks of pregnancy at the Clinical University Hospital 'San Cecilio' and "Mother-Infant" Hospital in the city of Granada, Spain
Key inclusion criteria (3 listed)
- healthy pregnant women aged between 18 and 42
- singleton pregnancies
- pregnancy stage at recruitment: 12 weeks of pregnancy
Key exclusion criteria (5 listed)
- Women who wish to participate in the study should not simultaneously participate in other research studies.
- Must be completely enclosed in one of the study of the groups without any possibility to be simultaneously incorporated on more groups of the study
- Mothers which are receiving any drug treatment, folate more than the 3rd first months, or DHA +/- vitamin supplements during pregnancy.
- Mothers affected by any disease other than those referred to the inclusion criteria, such hypertension or pre-eclampsia, foetal IUGR, mother infection during pregnancy, hypothyroidism / hyperthyroidism, hepatic diseases, renal disease,…
- Mothers following an extravagant diet or vegan diet.
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
Long-term evidence of early human programming of obesity measured by nutritional biomarkers, and the offspring growth and development.
Time frame: Participants will be followed for the duration of the study, an expected average of 6 years
Long-term evidence of early human programming of obesity measured by genetic biomarkers, and the offspring growth and development.
Time frame: Participants will be followed for the duration of the study, an expected average of 6 years
Long-term evidence of early human programming of obesity measured biochemical perinatal biomarkers, and the offspring growth and development.
Time frame: Participants will be followed for the duration of the study, an expected average of 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
- Results publication: PubMed 20205964Santacruz A, Collado MC, Garcia-Valdes L, Segura MT, Martin-Lagos JA, Anjos T, Marti-Romero M, Lopez RM, Florido J, Campoy C, Sanz Y. Gut microbiota composition is associated with body weight, weight gain and biochemical parameters in pregnant women. Br J Nutr. 2010 Jul;104(1):83-92. doi: 10.1017/S0007114510000176. Epub 2010 Mar 8.
- Results publication: PubMed 19132267Campoy C, Martin-Bautista E, Garcia-Valdes L, Florido J, Agil A, Lorente JA, Marcos A, Lopez-Sabater MC, Miranda-Leon T, Sanz Y, Molina-Font JA; grupo PREOBE. [Study of maternal nutrition and genetic on the foetal adiposity programming (The PREOBE study)]. Nutr Hosp. 2008 Nov-Dec;23(6):584-90. Spanish.
- Derived from this study: PubMed 38052208Cerdo T, Ruiz-Rodriguez A, Acuna I, Torres-Espinola FJ, Menchen-Marquez S, Gamiz F, Gallo M, Jehmlich N, Haange SB, von Bergen M, Campoy C, Suarez A. Infant gut microbiota contributes to cognitive performance in mice. Cell Host Microbe. 2023 Dec 13;31(12):1974-1988.e4. doi: 10.1016/j.chom.2023.11.004. Epub 2023 Dec 4.
- Derived from this study: PubMed 26931143Berglund SK, Garcia-Valdes L, Torres-Espinola FJ, Segura MT, Martinez-Zaldivar C, Aguilar MJ, Agil A, Lorente JA, Florido J, Padilla C, Altmae S, Marcos A, Lopez-Sabater MC, Campoy C; PREOBE team. Maternal, fetal and perinatal alterations associated with obesity, overweight and gestational diabetes: an observational cohort study (PREOBE). BMC Public Health. 2016 Mar 1;16:207. doi: 10.1186/s12889-016-2809-3.
- Derived from this study: PubMed 26208217Torres-Espinola FJ, Berglund SK, Garcia-Valdes LM, Segura MT, Jerez A, Campos D, Moreno-Torres R, Rueda R, Catena A, Perez-Garcia M, Campoy C; PREOBE team. Maternal Obesity, Overweight and Gestational Diabetes Affect the Offspring Neurodevelopment at 6 and 18 Months of Age--A Follow Up from the PREOBE Cohort. PLoS One. 2015 Jul 24;10(7):e0133010. doi: 10.1371/journal.pone.0133010. eCollection 2015.
- Derived from this study: PubMed 26025336Torres-Espinola FJ, Altmae S, Segura MT, Jerez A, Anjos T, Chisaguano M, Carmen Lopez-Sabater M, Entrala C, Alvarez JC, Agil A, Florido J, Catena A, Perez-Garcia M, Campoy C. Maternal PPARG Pro12Ala polymorphism is associated with infant's neurodevelopmental outcomes at 18 months of age. Early Hum Dev. 2015 Aug;91(8):457-62. doi: 10.1016/j.earlhumdev.2015.05.001. Epub 2015 May 26.
- Derived from this study: PubMed 26021978Uhl O, Demmelmair H, Segura MT, Florido J, Rueda R, Campoy C, Koletzko B. Effects of obesity and gestational diabetes mellitus on placental phospholipids. Diabetes Res Clin Pract. 2015 Aug;109(2):364-71. doi: 10.1016/j.diabres.2015.05.032. Epub 2015 May 16.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Cristina Campoy, Professor, MD study director
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes, run by Universidad de Granada at 1 site in Spain.
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 3 inclusion and 5 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 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 Cristina Campoy, Professor, MD (0034 629308695, ccampoy@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term evidence of early human programming of obesity measured by nutritional biomarkers, and the offspring growth and development. (time frame: Participants will be followed for the duration of the study, an expected average of 6 years). The study lists 3 primary outcomes in all. 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 NCT01634464, 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 9 Jul 2012.