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Completed

NCT Number: NCT03145649

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary therapy or insulin injection

Other

Primary outcomes

  1. Adiponectin in the colostrum

    Time frame: Day 3 after delivery

    Adiponectin concentration in the colostrum

  2. Leptin in the colostrum

    Time frame: Day 3 after delivery

    Leptin concentration in the colostrum

  3. Insulin in the colostrum

    Time frame: Day 3 after delivery

    Insulin concentration in the colostrum

  4. Ghrelin in the colostrum

    Time frame: Day 3 after delivery

    Ghrelin concentration in the colostrum

  5. Adiponectin in the early mature milk

    Time frame: Day 42 after delivery

    Adiponectin concentration in the mature milk of day 42

  6. Leptin in the early mature milk

    Time frame: Day 42 after delivery

    Leptin concentration in the mature milk of day 42

  7. Insulin in the early mature milk

    Time frame: Day 42 after delivery

    Insulin concentration in the mature milk of day 42

  8. Ghrelin in the early mature milk

    Time frame: Day 42 after delivery

    Ghrelin concentration in the mature milk of day 42

  9. Adiponectin in the mature milk

    Time frame: Day 90 after delivery

    Adiponectin concentration in the mature milk of day 90

  10. Leptin in the mature milk

    Time frame: Day 90 after delivery

    Leptin concentration in the mature milk of day 90

  11. Insulin in the mature milk

    Time frame: Day 90 after delivery

    Insulin concentration in the mature milk of day 90

  12. Ghrelin in the mature milk

    Time frame: Day 90 after delivery

    Ghrelin concentration in the mature milk of day 90

  13. Infant birth weight

    Time frame: At birth

    Infants' weight at birth

  14. Infant birth height

    Time frame: At birth

    Infants' height at birth

  15. Infant birth head circumference

    Time frame: At birth

    Infants' head circumference at birth

  16. Infant weight at day 42

    Time frame: Day 42

    Infants' weight at day 42

  17. Infant height at day 42

    Time frame: Day 42

    Infants' height at day 42

  18. Infant head circumference at day 42

    Time frame: Day 42

    Infants' head circumference at day 42

  19. Infant weight at day 90

    Time frame: Day 90

    Infants' weight at day 90

  20. Infant height at day 90

    Time frame: Day 90

    Infants' height at day 90

  21. Infant head circumference at day 90

    Time frame: Day 90

    Infants' head circumference at day 90

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 9, 2017
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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