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

NCT03957603 | Completed

• 1 other identifier: 2017-KY-061-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Change in HbA1c from Baseline at 2 months

  Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery

• Insulin treatmeant ratio

  From enrollment to delivery

• Change in serum glycated albumin from Baseline at 2 months

  Gestational age 24-28weeks and 32-34weeks and 36-40 weeks and 42-70days after delivery

• Change in fasting blood glucose concentration from Baseline at 2 months

  Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery

• Change in Fasting insulin concentration from Baseline at 2 months

  Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery

Secondary Outcomes (4)

• Oral glucose tolerance test

  Gestational age 24-28 weeks and 42-70 days after delivery

• The insulin sensitivity (HOMA-IS)

  From enrollment to the 42 days after delivery

• Gestational weight gain

  From enrollment to the 42 days after delivery

• The incidence of macrosomia infants

  From enrollment to delivery

Study Arms (2)

TPF-DM Combined with Medical Nutrition Therapy Intervention

EXPERIMENTAL

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.

Dietary Supplement: Enteral Nutrition Suspension (TFP-DM)

Medical Nutrition Therapy Intervention

ACTIVE COMPARATOR

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.

Behavioral: Medical Nutrition Therpay

Interventions

Enteral Nutrition Suspension (TFP-DM) DIETARY_SUPPLEMENT

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

TPF-DM Combined with Medical Nutrition Therapy Intervention

Medical Nutrition Therpay BEHAVIORAL

Individualized dietary and lifestyle intervention

Medical Nutrition Therapy Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead
• Zhejiang University School of Medicine, Obstetrics and Gynecology Hospital: collaborator
• Nutricia Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, 100026, China

Location

Related Publications (1)

• 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.

  PMID: 39536397 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Gestational Weight Gain

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; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guanghui Li, MD, PhD

  Beijing Obstetrics and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 21, 2019
• Study Start: May 16, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

CN (1)