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

May 5, 2017 updated by: Peking Union Medical College Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects 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. The exclusion criteria were: pre-pregnancy diabetes, fetal anomaly, gestational hypertension, preeclampsia, fetal growth restriction, ruptured membranes, postpartum glucose abnormalities (see below), and introduction of formula feeding during the follow-ups. Women with plasma glucose>7.8mmol/L in the 1-hour 50g glucose load test (GLT) during the 24th-28th gestational weeks underwent a 3-hour 100g diagnostic oral glucose tolerance test (OGTT) following a 12-hour overnight fast. GDM was diagnosed if two or more plasma glucose reads in the OGTT equaled or exceeded the threshold according to Carpenter and Coustan. All subjects diagnosed with GDM initially received dietary therapy to attain glycemic targets: 3.3-5.6 mmol/L at fasting, 3.3-5.8 mmol/L pre-prandially, 4.4-6.7 mmol/L 2-hours post-prandially, and 4.4-6.7 mmol/L at night. The participants were followed by dietitians to ensure euglycemia, appropriate weight gain, and adequate nutritional intake. The participants who did not attain glycemic targets in 2 weeks after starting the dietary therapy were given insulin via injection. As macronutrients in BM were mainly determined by the maternal glucose metabolic status, the investigators excluded women with postpartum glucose abnormalities, i.e., impaired glucose tolerance (IGT) with the 2-hour plasma glucose between 7.8 and 11.0 mmol/l and type 2 diabetes with the 2-hour plasma glucose ≥11.1 mmol/l in the 75g OGTT on postpartum day 42.

Anthropometric measurements Data was recorded using customized case report forms. Obstetric data, such as glycemic tests, gestational age, and mode of delivery, were retrieved from the medical records. Pre-pregnancy weight was self-reported. Mothers' height was measured twice to the nearest 0.1 cm with a wall-mounted stadiometer. Mothers' weight was measured twice to the nearest 0.1 kg with a medical balance scale before delivery, on postpartum days 42 and 90. The weight, length, and head circumference of the infants were measured at birth, on days 42 and 90. The infants were weighed twice in nude using a precision scale (Seca, CA, USA). Body length and head circumference were measured twice to the nearest 0.1 cm with a length board and non-stretchable measuring tapes (Seca, CA, USA). The mean values of the two readings were used for data analysis.

Milk sample collection, processing, and laboratory tests Colostrum samples were collected between 8 a.m. and 9 a.m. before infant feeding on the third day after delivery. Mature milk, including both foremilk and hindmilk, was delivered and collected from one breast before infant feeding using an electric pump (Medela, Baar, Switzerland) between 2 p.m. and 4 p.m. on days 42 and 90 in the clinics. The milk samples were frozen immediately in sterilized plastic tubes at -80°C. Before quantifying the hormones in BM, the samples were thawed at 4°C, sonicated, and centrifuged. The samples were sonicated using a sonicator (Braun-sonic sonicator, B. Braun, Melsungen, Germany) at 50 watts for 3 bursts with 10-second intervals, and centrifuged at 100,000g for 1 hour at 4°C. The supernatant fat was discarded and the skim milk was used for quantifying adiponectin, leptin, insulin, and ghrelin by ELISA at the Key Laboratory of Endocrinology in the Peking Union Medical College Hospital. The assay had an intra- and inter-assay CV of <5.4 and <8.5% for adiponectin, and <7.4% and <9.3% for leptin, respectively. The insulin assay had no cross-reactivity to proinsulin (<0.05%), and had sensitivity of 0.5 mU/L and an inter-assay CV of <9.0%. Total ghrelin was tested using the total human ghrelin ELISA kit (Millipore, USA). The intra- and inter-assay CVs for the ghrelin assay were <1.9% and <7.7%.

Study Type

Observational

Enrollment (Actual)

96

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adiponectin in the colostrum
Time Frame: Day 3 after delivery
Adiponectin concentration in the colostrum
Day 3 after delivery
Leptin in the colostrum
Time Frame: Day 3 after delivery
Leptin concentration in the colostrum
Day 3 after delivery
Insulin in the colostrum
Time Frame: Day 3 after delivery
Insulin concentration in the colostrum
Day 3 after delivery
Ghrelin in the colostrum
Time Frame: Day 3 after delivery
Ghrelin concentration in the colostrum
Day 3 after delivery
Adiponectin in the early mature milk
Time Frame: Day 42 after delivery
Adiponectin concentration in the mature milk of day 42
Day 42 after delivery
Leptin in the early mature milk
Time Frame: Day 42 after delivery
Leptin concentration in the mature milk of day 42
Day 42 after delivery
Insulin in the early mature milk
Time Frame: Day 42 after delivery
Insulin concentration in the mature milk of day 42
Day 42 after delivery
Ghrelin in the early mature milk
Time Frame: Day 42 after delivery
Ghrelin concentration in the mature milk of day 42
Day 42 after delivery
Adiponectin in the mature milk
Time Frame: Day 90 after delivery
Adiponectin concentration in the mature milk of day 90
Day 90 after delivery
Leptin in the mature milk
Time Frame: Day 90 after delivery
Leptin concentration in the mature milk of day 90
Day 90 after delivery
Insulin in the mature milk
Time Frame: Day 90 after delivery
Insulin concentration in the mature milk of day 90
Day 90 after delivery
Ghrelin in the mature milk
Time Frame: Day 90 after delivery
Ghrelin concentration in the mature milk of day 90
Day 90 after delivery
Infant birth weight
Time Frame: At birth
Infants' weight at birth
At birth
Infant birth height
Time Frame: At birth
Infants' height at birth
At birth
Infant birth head circumference
Time Frame: At birth
Infants' head circumference at birth
At birth
Infant weight at day 42
Time Frame: Day 42
Infants' weight at day 42
Day 42
Infant height at day 42
Time Frame: Day 42
Infants' height at day 42
Day 42
Infant head circumference at day 42
Time Frame: Day 42
Infants' head circumference at day 42
Day 42
Infant weight at day 90
Time Frame: Day 90
Infants' weight at day 90
Day 90
Infant height at day 90
Time Frame: Day 90
Infants' height at day 90
Day 90
Infant head circumference at day 90
Time Frame: Day 90
Infants' head circumference at day 90
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2010

Primary Completion (Actual)

October 21, 2010

Study Completion (Actual)

July 16, 2011

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D111100000611001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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