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White Adipose Tissue in Pregnancy Study (WAT)

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ClinicalTrials.gov Identifier: NCT02495987
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
This study aims to understand the role of metabolic tissues in the changes of the metabolism of pregnant women and whether this contributes to some women developing metabolic diseases of pregnancy such as gestational diabetes (GDM) or intrahepatic cholestasis of pregnancy (ICP). Samples of adipose tissue will be taken when pregnant women are having caesarean section or laparoscopic procedures.

Condition or disease
ICP GDM

Detailed Description:

There is a gradual change in metabolism in pregnancy. This is characterised by a switch from normal levels of cholesterol, glucose and bile acids in early pregnancy to high levels of lipids, glucose and bile acids in late pregnancy. This is important to ensure that nutrients are provided for the growing fetus. However, it results in some women developing metabolic diseases of pregnancy, e.g. gestational diabetes mellitus (GDM) or intrahepatic cholestasis of pregnancy (ICP).

This project aims to understand the role of metabolic tissues in the changes of the metabolism of pregnant women. The investigators are asking for permission to collect samples of adipose tissue (subcutaneous and visceral fat) when women are having surgical procedures. Specifically, the investigators would like to take small samples of fat at two time points:

  1. When having a caesarean section (3rd trimester of pregnancy)
  2. When having laparoscopic surgery for ectopic pregnancy (1st trimester of pregnancy) Samples will only be taken from women having surgery as part of their clinical care. The investigators are requesting permission to collect samples from women with metabolic diseases of pregnancy (GDM and ICP) and matched controls (women with uncomplicated pregnancy). The investigators will also want to collect blood samples.

There is evidence from non-pregnant individuals (and from animal studies) that the adipose tissue in different parts of the body function in different ways. Subcutaneous fat is typically a fat storage tissue while visceral adipose tissue plays a role in metabolism of fat. The investigators' studies in mice suggest that these different fat stores function differently in pregnancy, and they may play a role in the metabolic changes that cause dyslipidaemia and susceptibility to diabetes mellitus. The investigators aim to identify where there are similar changes in function of adipose tissue in human pregnancy, and whether this contributes to the development of GDM and ICP.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Adaptations in Subcutaneous and Visceral Adipose Tissue Metabolism During Normal and Pathological Pregnancies
Study Start Date : March 2015
Estimated Primary Completion Date : February 9, 2020
Estimated Study Completion Date : February 9, 2020



Primary Outcome Measures :
  1. To establish whether there is altered function of subcutaneous and visceral fat in the 1st or 3rd trimester of normal pregnancy, ICP or GDM and whether this is associated with alterations in serum lipids and bile acids [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To establish whether there are changes in subcutaneous or visceral fat function associated with altered levels of incretins, free fatty acids or other metabolites of relevance to bile acid, lipid or glucose metabolism. [ Time Frame: 3 years ]
  2. To establish whether there are changes in the histological appearance of subcutaneous or visceral fat in the first or third trimester of normal pregnancy, ICP or GDM [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA
Adipose tissue, serum


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with or without ICP or GDM
Criteria

Inclusion Criteria:

  • Pregnant women 18-50 years of age
  • Uncomplicated pregnancies
  • Pathological pregnancies such as Type II Diabetes and ICP

Exclusion Criteria:

  • Women treated with immunosuppressive agents, e.g. azathioprine.
  • Type 1 diabetes mellitus.
  • Long-standing treatment with glucocorticoids, e.g. prednisolone
  • Hepatitis C, hepatitis B or HIV.
  • Women unable to give consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495987


Contacts
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Contact: Jenny Chambers 0208 383 5285 jenny.chambers@imperial.ac.uk

Locations
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United Kingdom
Guy's & St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Jenny Chambers    0208 3835285    jenny.chambers@imperial.ac.uk   
Imperial College Healthcare NHS Trust Hammersmith Recruiting
London, United Kingdom
Contact: Jenny Chambers    0208 3835285      
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Catherine Williamson, MBChB Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02495987    
Other Study ID Numbers: 14HH2393
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will publish our results and findings in research publications.