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

Gestational Diabetes Clinical Trial

Official title:

Women's Hospital of Nanjing Medical University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05629403
• Other study ID #: NanjingMU2022
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: November 2022
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 1, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Feeding
• Diabetes, Gestational
• Gestational Diabetes
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Other:
• observe
no intervention

Locations

Country	Name	City	State
China	Nanjing Maternal and child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

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