Diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
This study aims to determine if diet is an effective way to manage glucose levels during pregnancy in a diverse population of pregnant women with diabetes. To investigate this, the researchers will re
(ii) offer researchers access to their clinical urine sample for analysis
(iii) provide an additional blood sample (10 ml) at three clinical visits
and (iv) to perform specific tasks in their own home related to diet and physical activity that they are comfortable with (outlined below).
Study design:
This study ha
and 2) an optional nested cross-over dietary intervention study to compare two specially designed meals, that differ in carbohydrate quality, to evaluate the effect of carbohydrate quality on CGM gluc
Sponsors
University of Leeds
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 18-45 years 2. Singleton pregnancy 3. Pregnant women in the first trimester of pregnancy 4. Diagnosed with either type 1 or type 2 diabetes mellitus
Exclusion criteria
Exclusion criteria: 1. Women aged under 18 or above 45 years 2. Women presenting after 14 weeks gestation 3. Multiple pregnancy 4. Foetal congenital abnormality 5. No diagnosis of diabetes 6. Diagnosis of gestational diabetes 7. Significant co-existent medical condition (e.g. overt diabetes complications, cancer, gut mobility or digestion disorder) 8. Significant psychological (e.g. anorexia, bulimia) and/or mental disorders which undermines informed consent 9. Dietary allergies or intolerance (for the standardised meals 10. Lack of internet access on a computer or tablet at home 11. Unable to understand written English and provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measures of (dys)glycaemia (e.g. CGM data, HbA1c) accessed at approximately 10-12, 18-20, and 28-34 weeks' gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Medical details of health, pregnancy, and delivery collected via routine care at the diabetes in pregnancy clinic at Leeds Teaching Hospitals NHS Trust on three occasions at ~10-12, 18-20, and 28-34 weeks of gestation 2. Lifestyle information: 2.1. Maternal dietary intake recorded using the myFood24 app over 3 days (2 weekdays and 1 weekend) 2.2. Physical activity and sleep recorded using Pregnancy Physical Activity Questionnaire (PPAQ) and Leeds Sleep Evaluation Questionnaire (LSEQ) questionnaires, respectively, on three occasions at ~10-12, 18-20, and 28-34 weeks of gestation 3. Metabolomics and genetic analysis using urine and blood samples on three occasions at ~10-12, 18-20, and 28-34 weeks of gestation | — |
Countries
England, United Kingdom
Outcome results
None listed