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Not Yet Recruiting NCT07069855

Nutcracker: Can Almond Nut Consumption Improve Nocturnal Glycaemic Control in Women With Gestational Diabetes Mellitus?

Conditions: Gestational Diabetes

Sex: Female
Ages: 16 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 156
Sponsor: Guy's and St Thomas' NHS Foundation Trust

Summary

Gestational diabetes, affecting over one in six births globally, is a growing public health concern. Characterised by high blood glucose, it increases the risk of pregnancy complications and raises the mother's long-term risk of type 2 diabetes. Managing high fasting glucose, which reflects elevated overnight levels, is a key challenge. Night-time snacking-more common in women with gestational diabetes-is linked to higher fasting glucose, but the impact of snack quality is unclear. Almonds have been shown to improve glucose control in non-pregnant adults. This study will test whether almonds, as a night-time snack, can improve overnight glucose levels in pregnant women with gestational diabetes. Findings could support a simple, effective dietary strategy to improve outcomes for mothers and babies worldwide.

Eligibility Criteria

Inclusion Criteria: 1. Age over 16 years 2. Singleton pregnancy 3. 25 to 31+6 weeks' gestation diagnosed with GDM using a standard clinical 75g oral glucose tolerance test (OGTT), as per the guidelines of the National Institute of Health and Care Excellence (NICE), and had their first post-diagnosis consultation (approx. 7-10 days later). The NICE criteria state that the diagnosis of GDM will be made with one or more glucose concentrations during the OGTT of \>5.6 mmol/l in the fasting state; \>7.8 mmol/l 2 hours after 75g glucose 4. Planned antenatal care at the same centre 5. GDm-Health (a digital app for the management of diabetes in pregnancy) used as part of their management for GDM 6. Willing and able to give informed consent Exclusion Criteria: 1. Age under 16 years or over 55 years 2. Multiple pregnancy 3. Non-snack consumers 4. Smokers 5. Women who would work night shifts over the study period 6. Women who have already commenced insulin for the treatment of GDM 7. Allergy or intolerance to nuts 8. Pre-existing medical conditions, including Type 1 or Type 2 diabetes, chronic coronary, renal or bowel disease or history of cholestatic liver disease or pancreatitis. Presence of gastrointestinal disorder or use of a drug which is likely to alter gastrointestinal motility or nutrient absorption, previous bariatric surgery 9. Unwilling or unable to give informed consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07069855). StuddyBuddy aggregates publicly available trial information.