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ObesityPlacentA-DMNCT02211651

Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM)

An observational study of Obesity and Type 2 Diabetes, run by AdventHealth Translational Research Institute at 1 site in United States.

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

The purpose of this study is to discover the characteristics of pregnant women which increases risk for their babies to develop diabetes, later on in life. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Type 2 Diabetes
How many people
3 participants
Where
1 siteUnited States
Study dates
Dec 2013to Jan 2017
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Vulnerable populations- Pregnant Women, Fetuses and Neonates Propose to study pregnant women in order to determine the relevant phenotype with offspring at risk for obesity and T2DM.

Pregnant women Inclusion Criteria:

  • Pregnant women undergoing planned cesarean section at 39 weeks of gestation due to: a) elective cesarean section; b) breach presentation c) repeat cesarean section (the rationale for choosing these women is to select only women that have no other risk factors or complications during pregnancy that might affect the outcome)
  • Age between 18 and 40 years old
  • Pre-pregnancy BMI between 20 and 25 kg/m2 (lean) and >30 kg/m2 (obese)
  • Singleton pregnancies
  • Allowing their neonates to participate in the trial

Pregnant women Exclusion Criteria:

  • Taking any medication except pre-natal vitamins and medication to treat normal symptoms of pregnancy like: constipation, nausea, vomiting, gastric reflux, insomnia and pain.
  • Type 1 diabetes, type 2 diabetes or gestational diabetes; chronic or gestational hypertension
  • Pre-eclampsia, eclampsia during this pregnancy
  • Liver, kidney, thyroid disease, cancer
  • Smoking or using illegal drugs or alcohol during this pregnancy
  • Fetal umbilical blood and/or placenta are collected for another reason, i.e. parents decide on cord blood storage

Neonate Inclusion criteria:

  • Live neonates born to the study participating mothers

Neonate exclusion criteria:

  • Neonate distress as to require admission to the Neonatal Intensive Care Unit.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Translational Research Institute for Metabolism and Diabetes

    Orlando, Florida, 32804

Other trials in United States

About this study

The purpose of this study is to discover the characteristics of pregnant women which increases risk for their babies to develop diabetes, later on in life.

Read the detailed description

Obesity has been recently diagnosed in a younger population and currently in the United States more than two thirds of women of childbearing age are overweight or obese. These women will have children at high risk for developing obesity and Type 2 diabetes (T2DM). There is an acute need for preventing these complications in children so that we can break the cycle of obesity and T2DM. Numerous interventions have attempted but failed to improve outcomes in obese pregnancies by weight loss. Clinicians do not currently have specific recommendation for identifying the obese mothers and risk and for the prevention of infant's complication in healthy obese pregnancies.

The global objective of this study is to identify the relevant maternal phenotype at risk and the mechanism(s) of fetal environment predisposing the offspring for T2DM. This will enhance T2DM early screening and prevention.

The global hypothesis is that dysfunctional adipose tissue secretes angiostatic and pro-inflammatory factors that lead to the formation of a dysfunctional placenta, which through a hypoxic and inflamed environment alters the epigenome to program the fetus for T2DM.

Keywords
adipose tissue, placenta, pregnancy, umbilical cord
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02211651
Study groupRoleWhat they receive
ObeseDYSObese subjects with dysfunctional vascularization and inflammation of placenta.
ObeseNLObese subjects with normal vascularization and inflammation of placenta
LeanNLLean subjects with normal vascularization and inflammation of placenta.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantity of Blood Vessels and Capillaries

    Measurements will be immunohistochemistry and measured from placental tissue. Neonate's anthropometrics and sex will be recorded within 48 hours of the delivery by the Pediatrician and will last approximately 15 minutes.

    Measured: Visit 3, at 39 weeks

  2. Quantity of macrophages

    Measured by immunohistochemistry, flow cytometry (FACS) of placental tissue

    Measured: Visit 3 at 39 weeks + 1 day

Timeline

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

  1. First posted7 Aug 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2016
  4. Study completionJan 2017

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02211651
Sponsor's protocol ID
TRIMDFH 499458
Other IDs
499458
Acronym
PlacentA-DM
Status last verified
Apr 2018
First submitted
16 May 2014
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Ling C, Groop L. Epigenetics: a molecular link between environmental factors and type 2 diabetes. Diabetes. 2009 Dec;58(12):2718-25. doi: 10.2337/db09-1003. No abstract available.

    PubMed 19940235

  • Dabelea D, Crume T. Maternal environment and the transgenerational cycle of obesity and diabetes. Diabetes. 2011 Jul;60(7):1849-55. doi: 10.2337/db11-0400. No abstract available.

    PubMed 21709280

  • Sullivan EL, Smith MS, Grove KL. Perinatal exposure to high-fat diet programs energy balance, metabolism and behavior in adulthood. Neuroendocrinology. 2011;93(1):1-8. doi: 10.1159/000322038. Epub 2010 Nov 13.

    PubMed 21079387

  • Catalano PM, Farrell K, Thomas A, Huston-Presley L, Mencin P, de Mouzon SH, Amini SB. Perinatal risk factors for childhood obesity and metabolic dysregulation. Am J Clin Nutr. 2009 Nov;90(5):1303-13. doi: 10.3945/ajcn.2008.27416. Epub 2009 Sep 16.

    PubMed 19759171

  • Crume TL, Ogden L, Daniels S, Hamman RF, Norris JM, Dabelea D. The impact of in utero exposure to diabetes on childhood body mass index growth trajectories: the EPOCH study. J Pediatr. 2011 Jun;158(6):941-6. doi: 10.1016/j.jpeds.2010.12.007. Epub 2011 Jan 15.

    PubMed 21238981

  • Dabelea D, Mayer-Davis EJ, Lamichhane AP, D'Agostino RB Jr, Liese AD, Vehik KS, Narayan KM, Zeitler P, Hamman RF. Association of intrauterine exposure to maternal diabetes and obesity with type 2 diabetes in youth: the SEARCH Case-Control Study. Diabetes Care. 2008 Jul;31(7):1422-6. doi: 10.2337/dc07-2417. Epub 2008 Mar 28.

    PubMed 18375420

  • Catalano PM, Presley L, Minium J, Hauguel-de Mouzon S. Fetuses of obese mothers develop insulin resistance in utero. Diabetes Care. 2009 Jun;32(6):1076-80. doi: 10.2337/dc08-2077.

    PubMed 19460915

  • Mingrone G, Manco M, Mora ME, Guidone C, Iaconelli A, Gniuli D, Leccesi L, Chiellini C, Ghirlanda G. Influence of maternal obesity on insulin sensitivity and secretion in offspring. Diabetes Care. 2008 Sep;31(9):1872-6. doi: 10.2337/dc08-0432. Epub 2008 Jun 5.

    PubMed 18535193

  • Samuelsson AM, Matthews PA, Argenton M, Christie MR, McConnell JM, Jansen EH, Piersma AH, Ozanne SE, Twinn DF, Remacle C, Rowlerson A, Poston L, Taylor PD. Diet-induced obesity in female mice leads to offspring hyperphagia, adiposity, hypertension, and insulin resistance: a novel murine model of developmental programming. Hypertension. 2008 Feb;51(2):383-92. doi: 10.1161/HYPERTENSIONAHA.107.101477. Epub 2007 Dec 17.

    PubMed 18086952

  • Bayol SA, Simbi BH, Bertrand JA, Stickland NC. Offspring from mothers fed a 'junk food' diet in pregnancy and lactation exhibit exacerbated adiposity that is more pronounced in females. J Physiol. 2008 Jul 1;586(13):3219-30. doi: 10.1113/jphysiol.2008.153817. Epub 2008 May 8.

    PubMed 18467362

  • Muhlhausler BS, Duffield JA, McMillen IC. Increased maternal nutrition stimulates peroxisome proliferator activated receptor-gamma, adiponectin, and leptin messenger ribonucleic acid expression in adipose tissue before birth. Endocrinology. 2007 Feb;148(2):878-85. doi: 10.1210/en.2006-1115. Epub 2006 Oct 26.

    PubMed 17068138

  • Chang GQ, Gaysinskaya V, Karatayev O, Leibowitz SF. Maternal high-fat diet and fetal programming: increased proliferation of hypothalamic peptide-producing neurons that increase risk for overeating and obesity. J Neurosci. 2008 Nov 12;28(46):12107-19. doi: 10.1523/JNEUROSCI.2642-08.2008.

    PubMed 19005075

  • Walker CD, Naef L, d'Asti E, Long H, Xu Z, Moreau A, Azeddine B. Perinatal maternal fat intake affects metabolism and hippocampal function in the offspring: a potential role for leptin. Ann N Y Acad Sci. 2008 Nov;1144:189-202. doi: 10.1196/annals.1418.023.

    PubMed 19076377

  • Shankar K, Kang P, Harrell A, Zhong Y, Marecki JC, Ronis MJ, Badger TM. Maternal overweight programs insulin and adiponectin signaling in the offspring. Endocrinology. 2010 Jun;151(6):2577-89. doi: 10.1210/en.2010-0017. Epub 2010 Apr 6.

    PubMed 20371699

  • Aagaard-Tillery KM, Grove K, Bishop J, Ke X, Fu Q, McKnight R, Lane RH. Developmental origins of disease and determinants of chromatin structure: maternal diet modifies the primate fetal epigenome. J Mol Endocrinol. 2008 Aug;41(2):91-102. doi: 10.1677/JME-08-0025. Epub 2008 May 30.

    PubMed 18515302

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Type 2 Diabetes, run by AdventHealth Translational Research Institute at 1 site in United States.

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 25 Apr 2018. 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 United States. 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?

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.

What does the primary outcome measure?

Quantity of Blood Vessels and Capillaries (time frame: Visit 3, at 39 weeks). The study lists 2 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 NCT02211651, which also lists 31 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 25 Apr 2018.

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PlacentA-DM Clinical Trial NCT02211651 | AzTrials