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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027910

Enrollment

175

Registered

2022-03-10

Start date

2022-04-04

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

O24.4 E10 E66 U07.1

Interventions

Group 1: Healthy pregnant women: - before birth: health and socio-economic status are recorded by questionnaire - visit 1: up to 3 days after birth: blood collection and milk collection from the moth

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
-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. -To characterize the association of human milk metabolome and lipidome with maternal and infant metabolism. -To characterize associations of human milk metabolome and lipidome with infant growth measures.	—

Measure

Time frame

-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. -To characterize the association of human milk metabolome and lipidome with maternal and infant metabolism. -To characterize associations of human milk metabolome and lipidome with infant growth measures.

—

Countries

Germany

Contacts

Public ContactJohanna Ruf

Dr. von Haunersches Kinderspital, Abteilung Stoffwechsel und Ernährung

KIND.HOPE-Studie@med.uni-muenchen.de015254847923

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026