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

NCT ID: NCT03957603

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-16
• Study Completion Date: 2023-12-31

Brief 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.

Detailed Description

Design:

A randomized controlled trial in pregnant women with gestational diabetes mellitus (GDM) will be performed at 24-28 weeks of gestation until the 42 days after delivery. Participants will be randomly assigned to the control group (Medical Nutrition Therapy) or the intervention group (Medical Nutrition Therapy combined with TFP-DM). The control group will receive the individualized Medical Nutrition Therapy, which focuses on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The intervention group has two components. The first part has the same intervention with the control group. The second part has the additional Enteral Nutrition Suspension (TFP-DM, Diason 0.75 kcal/ml) intervention based on the standard Medical Nutrition Therapy. It meant 200ml/150Kcal TFP-DM will be suggested to participants in the intervention group 2 times per day. The 400ml TFP-DM will replace the 25 grams of grains and dairies during breakfast and the snack session after dinner. Overall, the control group and the intervention group will receive the same amount of carbohydrate and calorie intake. The primary outcome will be fasting plasma glucose concentration, HbA1c concentration. The secondary outcome will be serum glycated albumin, serum insulin concentration, the rate of using insulin for patients, the insulin sensitivity (HOMA-IS), the gestational weight gain, the incidence of macrosomic infants.

Hypothesis:

Medical nutrition therapy combined with the enteral nutrition suspension (TFP-DM, Diason 0.75 kcal/ml) in pregnant women with gestational diabetes mellitus (GDM) will improve in glucose and lipid metabolism and the relevant adverse pregnancy outcomes, and provide the evidence-based in clinical nutrition therapy for gestational diabetes mellitus (GDM) disease.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TPF-DM Combined with Medical Nutrition Therapy Intervention

Participants in the experimental group will be provided with an individualized dietary, nutrition recommendation and the additional Enteral Nutrition Suspension (TFP-DM, Diason 0.75 kcal/ml). Participants are required to schedule the first follow-up visit one week after receiving the individualized recommendations. Afterward, the regularly scheduled follow-up visit will be scheduled every two to four weeks.

Group Type: EXPERIMENTAL

Enteral Nutrition Suspension (TFP-DM)

Intervention Type: DIETARY_SUPPLEMENT

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

Medical Nutrition Therapy Intervention

Based on the standard care, Participants will receive an individualized dietary, nutrition recommendations with the application of food exchange porting. Participants are required to schedule the first follow-up visit one week after receiving the individualized recommendations. Afterward, the regularly scheduled follow-up visit will be scheduled every two to four weeks.

Group Type: ACTIVE_COMPARATOR

Medical Nutrition Therpay

Intervention Type: BEHAVIORAL

Individualized dietary and lifestyle intervention

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

Medical Nutrition Therpay

Individualized dietary and lifestyle intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Gestational age between 24 and 28 weeks of gestation
• Age >= 18 years
• Singleton pregnancy
• Two of three or three results of the oral glucose tolerance test (OGTT) are above the diagnostic criteria. (The diagnostic criteria for three results of OGTT: Fasting plasma glucose ≥ 5.1mmol/L, 1-hour OGTT plasma glucose ≥ 10.0mmol/L, 2-hour OGTT plasma glucose ≥ 8.5mmol/L)

Exclusion Criteria

• History of prenatal hypertension, diabetes, hyperlipidemias, liver disease, kidney disease, digestive tract disease and infectious disease (hepatitis, tuberculosis etc.)
• Gestational weeks < 24 or > 28
• Age < 18 years or Age > 45 years
• Multiple pregnancy
• Food allergic history
• Regular smoking, drinking alcohol
• Patients with the history of using the assisted reproductive technology
• Patients with psychiatric disorders that prevents correctly answer the questions
• Patients who are unable to answer the questionnaire questions
• Bariatric surgery history
• Non-adherence of dietary and lifestyle recommendation
• Threatened abortion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University School of Medicine, Obstetrics and Gynecology Hospital

UNKNOWN

Sponsor Role: collaborator

Nutricia Pharmaceutical Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Guanghui Li

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guanghui Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Obstetrics and Gynecology Hospital

Locations

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, , China

Countries

China

References

Yang R, Han W, Zheng W, Xu D, He J, Yuan X, Zhang L, Tian Z, Li G. 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. Clin Nutr. 2024 Dec;43(12):265-274. doi: 10.1016/j.clnu.2024.11.001. Epub 2024 Nov 6.

Reference Type: DERIVED

PMID: 39536397 (View on PubMed)

Other Identifiers

2017-KY-061-01

Identifier Type: -

Identifier Source: org_study_id