Individualised patient care and treatment for maternal diabetes - Trial ISRCTN57579163
Access comprehensive clinical trial information for ISRCTN57579163 through Pure Global AI's free database. This Not Applicable trial is sponsored by University of Leeds and is currently status unknown. The study focuses on Diabetes mellitus. Target enrollment is 76 participants.
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Study Focus
Sponsor & Location
University of Leeds
Wellcome Trust; Grant Codes: 217446/Z/19/Z
Timeline & Enrollment
Not Applicable
Oct 12, 2020
Feb 01, 2023
Summary
A. Main research question: How do diet and personal factors influence glucose responses in pregnant women with pre-existing diabetes? 1. What role does diet play as a mediator of dysglycemia over the course of pregnancy? Hypothesis: Pregnant women with pre-existing diabetes consuming a well-balanced diet (e.g. low glycemic index, reduced saturated fat and high fibre intake) will have improved glycemic control and reduced dysglycemia over the course of pregnancy compared consuming to an unbalanced diet (e.g. high glycemic index, increased saturated fat and low in fibre intake). 2. Which personal characteristics drive differences in dysglycemia? Hypothesis: Personal characteristics such as younger age, lower body mass index and non-minority ethnic background will have a positive impact on (dys)glycemia in pregnant women with pre-existing diabetes. B. Nested study: How do diet and personal factors influence glucose responses after a meal in pregnant women with pre-existing diabetes? 1. What role does diet play as a mediator of post-prandial glucose response over the course of pregnancy? Hypothesis: Pregnant women with pre-existing diabetes consuming a standardised breakfast meal replacement with a low glycemic index will have improved glycemic control after the meal over the course of pregnancy compared to consuming a standardised breakfast meal replacement with a high glycemic index. 2. Which personal characteristics drive differences in dysglycemia after a meal? Hypothesis: Personal characteristics such as younger age, lower body mass index and non-minority ethnic background will have a positive impact on (dys)glycemia after a meal in pregnant women with pre-existing diabetes.
ICD-10 Classifications
Data Source
ISRCTN Registry
ISRCTN57579163
Device Trial