Characterization of human milk lipids with bioactive potential and the impact of maternal diabetes mellitus on their compositio

• Conditions: O24.4; E10; E66; U07.1; Diabetes mellitus arising in pregnancy; Type 1 diabetes mellitus; Obesity; COVID-19, virus identified

• Registration Number: DRKS00027910
• Lead Sponsor: Dr. von Haunersches Kinderspital, Abteilung Stoffwechsel und Ernährung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

Healthy women and women with a history of GDM or of pre-existing Type 1 Diabetes
- Singleton pregnancy
- Reported pre pregnancy BMI: 18 - 35 kg/m2
- No serious medical disorder that is expected to affect lactation or metabolism
- Omnivorous or vegetarian diet
- Intention to fully breastfeed the infant for at least 4 month

Exclusion Criteria

- Maternal vegan or ketogenic-diet
- Maternal hypertension (with medication) or severe pre-eclampsia
- Chronic diseases assumed to affect maternal or infant metabolism or infant growth (other than Type 1 Diabetes), e.g. maternal Diabetes mellitus Type 2
- Severe pregnancy complications like severe pre-eclampsia or gestosis
- Pre-term delivery (< 37th gestational week)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of human milk lipids and metabolites that may have a bioactive effect on infant development considering a variety of potential influencing factors, including maternal gestational diabetes and type 1 diabetes.

Secondary Outcome Measures

Name	Time	Method
-To investigate the impact of stage of lactation and other maternal characteristics, such as maternal diet and lifestyle factors, BMI, Covid-19 infection and genotype, on human milk metabolome and lipidome. <br>-To characterize the association of human milk metabolome and lipidome with maternal and infant metabolism.<br>-To characterize associations of human milk metabolome and lipidome with infant growth measures.