NCT03957603

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

Completed NA Last updated 13 March 2024

What this trial tests

NA trial testing Enteral Nutrition Suspension (TFP-DM) in Medical Nutrition Therapy in 100 participants. Completed in 31 December 2023.

Timeline

16 May 2019

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Capital Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	16 May 2019
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across China

Drugs / interventions tested

• Enteral Nutrition Suspension (TFP-DM)
• Medical Nutrition Therpay

Conditions studied

• Medical Nutrition Therapy — all drugs for Medical Nutrition Therapy →
• Gestational Diabetes Mellitus — all drugs for Gestational Diabetes Mellitus →
• Adverse Pregnancy Outcomes — all drugs for Adverse Pregnancy Outcomes →
• Fasting Plasma Glucose — all drugs for Fasting Plasma Glucose →

Sponsor

Capital Medical University

Who can join

Adults 18 to 45, female only, with Medical Nutrition Therapy or Gestational Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Administration of a diabetes-specific formula can improve postprandial glycemic control and delay insulin use in gestational diabetes mellitus: A randomized controlled trial from two centers.
   Yang R, Han W, Zheng W, Xu D, et al · · 2024 · PMID 39536397 · DOI 10.1016/j.clnu.2024.11.001