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

NCT05629403 | Completed

• 1 other identifier: NanjingMU2022
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Gestational Diabetes; Breast Feeding; Lipid Metabolism Disorders

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

exclusive breastfeeding

breastfeeding exclusively

Other: observe

formula feeding

formula feeding

Other: observe

Interventions

observe OTHER

no intervention

exclusive breastfeeding; formula feeding

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Maternal and child Health Care Hospital

Nanjing, Jiangsu, 21004, China

Location

MeSH Terms

Conditions

Diabetes, Gestational; Breast Feeding; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: November 29, 2022
• Study Start: September 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: July 1, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)