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Medical Nutrition Therapy Combined With TPF-DM in Pregnant Women With Gestational Diabetes Mellitus

NCT03957603 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-13

No results posted yet for this study

Summary

Background:

Gestational diabetes mellitus (GDM), GDM is the first time of gestational impaired glucose tolerance in pregnant women. It is the most common complication disease in women of childbearing age. It is associated with the high risk of adverse health outcomes for both mothers and offsprings and the variety of metabolic disease, including type 2 diabetes, etc. As for the epidemiology data of GDM in China, the prevalence is around 18% based on the criteria from the International Association of Diabetes in Pregnancy Study Groups, IADPSG. Several studies claimed that the diabetes-specific formula improved glycemic control in type 2 diabetes patients. However, the effects of medical nutrition therapy combined with the diabetes-specific formula in pregnant women with gestational diabetes mellitus (GDM) are unclear.

Objective:

This study examines whether medical nutrition therapy combined with Enteral Nutrition Suspension (TFP-DM, Diason 0.75 kcal/ml) in GDM women could improve the glycemic control and the pregnancy outcomes.

Conditions

  • Medical Nutrition Therapy
  • Gestational Diabetes Mellitus
  • Adverse Pregnancy Outcomes
  • Fasting Plasma Glucose
  • HbA1c
  • Gestational Weight Gain

Interventions

DIETARY_SUPPLEMENT

Enteral Nutrition Suspension (TFP-DM)

Individualized dietary and lifestyle intervention combined with the recommendation of Enteral Nutrition Suspension (TPF-DM, Diason 0.75 kcal/ml)

BEHAVIORAL

Medical Nutrition Therpay

Individualized dietary and lifestyle intervention

Sponsors & Collaborators

  • Zhejiang University School of Medicine, Obstetrics and Gynecology Hospital

    collaborator UNKNOWN

  • Nutricia Pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Capital Medical University

    lead OTHER

Principal Investigators

  • Guanghui Li, MD, PhD · Beijing Obstetrics and Gynecology Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03957603 on ClinicalTrials.gov