Dingena, CF, Mahendra, A, Holmes, MJ et al. (3 more authors) (2023) Protocol for the INFORMED (Individualised Patient Care and Treatment for Maternal Diabetes) Study: a randomised controlled trial embedded within routine care. BMJ Open, 13 (2). e065388. ISSN 2044-6055
Abstract
Introduction Diabetes in pregnancy presents a unique physiological challenge to manage glycaemia while maintaining adequate nourishment for the growing fetus. Women with diabetes who become pregnant are at greater risk of adverse maternal and newborn outcomes, compared with women without diabetes. Evidence suggests that control of (postprandial) glycaemia is key to manage maternal and offspring health but it is not yet clear (1) how diet and lifestyle moderate these shifts across the full duration of pregnancy or (2) what aspects of maternal and offspring health are associated with dysglycaemia.
Methods and analysis To investigate these gaps, a cross-over randomised clinical trial has been embedded within routine clinical care. Seventy-six pregnant women in their first trimester with type 1 or type 2 diabetes (with or without medication) attending their routine antenatal appointments at National Health Service (NHS) Leeds Teaching Hospitals will be recruited. Following informed consent, data on women’s health, glycaemia, pregnancy and delivery will be shared by the NHS with researchers. At each visit in the first (10–12 weeks), second (18–20 weeks) and third (28–34 weeks) trimester, participants will be asked for consent to: (1) lifestyle and diet questionnaires, (2) blood for research purposes and (3) analysis of urine collected at clinical visits. Additionally, participants will be asked to consume two blinded meals in duplicate in second and third trimester. Glycaemia will be assessed by continuous glucose monitoring as part of routine care. The primary outcome is the effect of experimental meals (high vs low protein) on postprandial glycaemia. Secondary outcomes include (1) the association between dysglycaemia and maternal and newborn health, and (2) the association between maternal metabolic profiles in early pregnancy with dysglycaemia in later pregnancy.
Ethics and dissemination The Leeds East Research Ethics Committee and NHS (REC: 21/NE/0196) approved the study. Results will be published in peer-reviewed journals and disseminated to participants and the wider public.
Trial registration number ISRCTN57579163.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Environment (Leeds) > School of Food Science and Nutrition (Leeds) > FSN Nutrition and Public Health (Leeds) |
Funding Information: | Funder Grant number Wellcome Trust 217446/Z/19/Z |
Depositing User: | Symplectic Publications |
Date Deposited: | 28 Feb 2023 16:11 |
Last Modified: | 28 Feb 2023 16:11 |
Status: | Published |
Publisher: | BMJ Publishing Group |
Identification Number: | 10.1136/bmjopen-2022-065388 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:196823 |