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

NCT03145649 | Completed

• 1 other identifier: D111100000611001
• Study Type: observational
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gestational Diabetes

Keywords

Breast milk; Hormone; Infant growth; Gestational diabetes mellitus

Outcome Measures

Primary Outcomes (21)

• Adiponectin in the colostrum

  Adiponectin concentration in the colostrum

  Day 3 after delivery

• Leptin in the colostrum

  Leptin concentration in the colostrum

  Day 3 after delivery

• Insulin in the colostrum

  Insulin concentration in the colostrum

  Day 3 after delivery

• Ghrelin in the colostrum

  Ghrelin concentration in the colostrum

  Day 3 after delivery

• Adiponectin in the early mature milk

  Adiponectin concentration in the mature milk of day 42

  Day 42 after delivery

• Leptin in the early mature milk

  Leptin concentration in the mature milk of day 42

  Day 42 after delivery

• Insulin in the early mature milk

  Insulin concentration in the mature milk of day 42

  Day 42 after delivery

• Ghrelin in the early mature milk

  Ghrelin concentration in the mature milk of day 42

  Day 42 after delivery

• Adiponectin in the mature milk

  Adiponectin concentration in the mature milk of day 90

  Day 90 after delivery

• Leptin in the mature milk

  Leptin concentration in the mature milk of day 90

  Day 90 after delivery

• Insulin in the mature milk

  Insulin concentration in the mature milk of day 90

  Day 90 after delivery

• Ghrelin in the mature milk

  Ghrelin concentration in the mature milk of day 90

  Day 90 after delivery

• Infant birth weight

  Infants' weight at birth

  At birth

• Infant birth height

  Infants' height at birth

  At birth

• Infant birth head circumference

  Infants' head circumference at birth

  At birth

• Infant weight at day 42

  Infants' weight at day 42

  Day 42

• Infant height at day 42

  Infants' height at day 42

  Day 42

• Infant head circumference at day 42

  Infants' head circumference at day 42

  Day 42

• Infant weight at day 90

  Infants' weight at day 90

  Day 90

• Infant height at day 90

  Infants' height at day 90

  Day 90

• Infant head circumference at day 90

  Infants' head circumference at day 90

  Day 90

Study Arms (2)

Gestational diabetes mellitus

Women with gestational diabetes mellitus and their infants. The blood glucose of women with gestational diabetes mellitus was controlled by dietary therapy or insulin injection.

Other: Dietary therapy or insulin injection

Healthy

Healthy mother-infant dyads

Interventions

Dietary therapy or insulin injection OTHER

Gestational diabetes mellitus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects were recruited consecutively from the obstetric wards at the Peking Union Medical College Hospital and the Beijing Obstetrics and Gynecology Hospital.

You may qualify if:

• Nulliparous women with GDM and healthy women, who intended to exclusively breastfeed their singletons, were recruited consecutively from the obstetric wards at the Peking Union Medical College Hospital and the Beijing Obstetrics and Gynecology Hospital during the 37th gestational week.

You may not qualify if:

• Pre-pregnancy diabetes, fetal anomaly, gestational hypertension, preeclampsia, fetal growth restriction, ruptured membranes, postpartum glucose abnormalities, and introduction of formula feeding during the follow-ups.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Related Publications (36)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast milk specimens were collected from women during lactation period.

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Insulin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 9, 2017
• Study Start: January 12, 2010
• Primary Completion: October 21, 2010
• Study Completion: July 16, 2011
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share