Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition

Women's Hospital of Nanjing Medical University

Breastfeeding could effectively be associated with a lower risk of future type 2 diabetes (T2D) in women with gestational diabetes mellitus (GDM), but the short-term protective impact of puerperal breastfeeding on maternal metabolic recovery of GDM women remains unascertained. The investigators recruited GDM participants at 6-9 weeks postpartum and retrieved clinical diagnoses of GDM from electronic medical records. Feeding patterns were collected via phone calls. Glucose metabolism parameters and lipid profiling were performed on fasting plasma samples collected from patients 6-9 weeks postpartum (20 breastfeeding cases vs. 15 formula feeding cases).

Study Overview

• Status: Completed
• Conditions: Lipid Metabolism Disorders; Breast Feeding; Gestational Diabetes
• Intervention / Treatment: Other: observe

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 21004
      • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

women (aged 18-35 years) who delivered live-born infants equal to or greater than 37 weeks of gestation at the Women's Hospital of Nanjing Medical University (Nanjing, China) and were not using medications affecting glucose tolerance, lipid regulation and not planning another pregnancy within the next 2 years were enrolled. All the participants received 75g OGTT at 24-28 weeks of gestation and were diagnosed with GDM based on the IADPSG criteria (International Association of Diabetes and Pregnancy Study Groups Consensus Panel et al.). At 6-8 weeks postpartum, all the participants were administered regularly for a post-natal health check-up to classify the body and genitals basically restored status. Fasting plasma samples were collected to measure plasma glucose, and insulin, and reclassify glucose metabolic status. Frequency and amount of breastmilk feeding and formula feeding for each woman were evaluated by trained research staff via telephone calls.

Description

Inclusion Criteria:

1. 18-35 years old;
2. gestational age greater than 37 weeks;
3. Body Mass Index (BMI) before pregnancy 18.5-28kg/m2;
4. Have normal listening and speaking skills, can communicate, and are willing to participate in this study.

Exclusion Criteria:

1. abnormal glucose metabolism or diabetes has been diagnosed before pregnancy;
2. assisted reproduction;
3. GDM patients requiring drug treatment;
4. The use of blood lipid regulation drugs;
5. other pregnancy complications and complications;
6. Suffering from heart, malignant tumor, kidney and other major organ diseases;
7. associated with neurological dysfunction and cognitive impairment;
8. Failure to cooperate with follow-up observers.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
exclusive breastfeeding; breastfeeding exclusively	Other: observe; no intervention
formula feeding	Other: observe; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose	glucose (mmol/L) determined with human ELISA kits	At 6-8 weeks postpartum
insulin	insulin (mU/L) determined with human ELISA kits	At 6-8 weeks postpartum
c-peptide	c-peptide (ng/m) determined with human ELISA kits	At 6-8 weeks postpartum
HOMA-IR	fasting glucose and fasting glucose will be combined to report HOMA-IR	At 6-8 weeks postpartum

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: November 27, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 27, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Metabolic Diseases; Lipid Metabolism Disorders; Diabetes, Gestational
• Other Study ID Numbers: NanjingMU2022

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