White Adipose Tissue in Pregnancy Study

NCT02495987 | Active Not Recruiting

• 1 other identifier: 14HH2393
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

ICP; GDM

Outcome Measures

Primary Outcomes (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

  Alterations in subcutaneous and visceral fat messenger RNA (mRNA) will be measured using quantitative PCR by fold-change mRNA expression in reference to the control group: normal pregnancy).

  10 years

Secondary Outcomes (2)

• 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.

  10 years

• 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

  10 years

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with or without ICP or GDM

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Imperial College Healthcare NHS Trust Hammersmith

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Adipose tissue, serum

Study Officials

• Catherine Williamson, MBChB

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 14, 2015
• Study Start: March 1, 2015
• Primary Completion: March 30, 2025
• Study Completion: March 31, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)