CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
Dietary therapy or insulin injectionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03145649
NCT03145649N/ACompleted

Breast Milk Hormones and Early Infant Growth of Women With Gestational Diabetes Mellitus

Peking Union Medical College Hospital·observational·Posted May 9, 2017·Updated May 9, 2017

In Brief

An observational study evaluating Dietary therapy or insulin injection for Gestational Diabetes. Completed, enrolled 96 participants.

Detailed Summary

Background: Breastfeeding has been associated with attenuated risk of obesity and type 2 diabetes in children born to women with diabetes. However, breast milk (BM) components responsible for the protective effects remain to be unveiled. Objective: To evaluate the hormone concentrations in BM of women with gestational diabetes mellitus (GDM) and their influence on early infant growth. Design: The investigators followed nulliparous women with and without GDM and their breastfed term singletons. Women diagnosed with GDM received dietary therapy or insulin injection to maintain euglycemia during pregnancy. Hormone concentrations in BM (i.e., adiponectin, leptin, insulin, and ghrelin) were tested and infant growth was evaluated on days 3, 42 and 90. The investigators compared the hormone concentrations between the GDM and healthy groups, and tested the associations of hormone concentrations with maternal factors (i.e., BMI, plasma glucose concentration, gestational age, and delivery mode) and early infant growth. Hypothesis: Hormone concentrations in BM could be determined by multiple maternal factors, including metabolic and obstetrical factors. GDM should be a significant influencing factor for hormone concentrations in BM.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2017
Enrollment StartJan 12, 2010
Primary CompletionOct 21, 2010
Study CompletionJul 16, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.1 years ago

Interventions

Dietary therapy or insulin injectionother