ow Glycaemic Load Breakfast for the management of Gestational Diabetes Mellitus - A randomised controlled, cross-over, pilot clinical trial

Not Applicable

Recruiting

• Conditions: Gestational Diabetes; Metabolic and Endocrine - Diabetes; Reproductive Health and Childbirth - Antenatal care; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12623000425695
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-28
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

* BMI:>18 kg/m2
* Diagnosed with gestational diabetes mellitus prior to 28 weeks’ gestation, based on the Australasian Diabetes in Pregnancy Society (ADIPS) criteria (fasting glucose more than or equal to 5.1 mmol/L, 1-h glucose more than or equal to 10.0 mmol/L and/or 2-h glucose more than or equal to 8.5 mmol/L following a 2-h 75g oral glucose tolerance test),
* Singleton pregnancy
* Intending to deliver at Royal Prince Alfred Hospital Women and Babies

Exclusion Criteria

* Multiple pregnancy
* Physical or psychological conditions that contraindicate participation including history of an eating disorder
* Overt hypertriglyceridaemia (triglycerides > 5 mmol/L)
* Current metformin or insulin therapy
* Smoking
* Current breastfeeding
* Special dietary requirements (e.g. coeliac disease, veganism); nut allergy or lactose intolerance
* Pre-existing diabetes or diabetes mellitus in pregnancy
* Gestational diabetes mellitus diagnosed after 28 weeks’ gestation defined by ADIPS criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified