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OpenTrials
Completed

NCT Number: NCT05629403

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

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).

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Nanjing Maternal and child Health Care Hospital

Nanjing, Jiangsu, 21004, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-35 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.

Exclusion criteria

  • 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.

Treatment and study plan

observe

Other

no intervention

Primary outcomes

  1. glucose

    Time frame: At 6-8 weeks postpartum

    glucose (mmol/L) determined with human ELISA kits

  2. insulin

    Time frame: At 6-8 weeks postpartum

    insulin (mU/L) determined with human ELISA kits

  3. c-peptide

    Time frame: At 6-8 weeks postpartum

    c-peptide (ng/m) determined with human ELISA kits

  4. HOMA-IR

    Time frame: At 6-8 weeks postpartum

    fasting glucose and fasting glucose will be combined to report HOMA-IR

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Women's Hospital of Nanjing Medical University

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2022
Registry last updated
Nov 29, 2022

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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