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

Completed

• Conditions: Gestational Diabetes; Breast Feeding; Lipid Metabolism Disorders
• Interventions: Other: observe

• Registration Number: NCT05629403
• Lead Sponsor: Nanjing Medical University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-03-30
• Study Completion: 2022-07-01
• Study First Submitted: 2022-07-07
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-27
• Last Update Submitted: 2022-11-27
• Study First Posted: 2022-11-29
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
exclusive breastfeeding	observe	breastfeeding exclusively
formula feeding	observe	formula feeding

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nanjing Maternal and child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China