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

Primary Purpose

Medical Nutrition Therapy, Gestational Diabetes Mellitus, Adverse Pregnancy Outcomes

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Enteral Nutrition Suspension (TFP-DM)
Medical Nutrition Therpay
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medical Nutrition Therapy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Obstetrics and Gynecology Hospital,Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TPF-DM Combined with Medical Nutrition Therapy Intervention

Medical Nutrition Therapy Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in HbA1c from Baseline at 2 months
Insulin treatmeant ratio
Change in serum glycated albumin from Baseline at 2 months
Change in fasting blood glucose concentration from Baseline at 2 months
Change in Fasting insulin concentration from Baseline at 2 months

Secondary Outcome Measures

Oral glucose tolerance test
The insulin sensitivity (HOMA-IS)
Gestational weight gain
The incidence of macrosomia infants

Full Information

First Posted
May 14, 2019
Last Updated
July 26, 2021
Sponsor
Capital Medical University
Collaborators
Zhejiang University School of Medicine, Obstetrics and Gynecology Hospital, Nutricia Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03957603
Brief Title
Medical Nutrition Therapy Combined With TPF-DM in Pregnant Women With Gestational Diabetes Mellitus
Official Title
Effects of Medical Nutrition Therapy Combined With TPF-DM in Pregnant Women With Gestational Diabetes Mellitus on Blood Glucose Fluctuations and Pregnancy Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
Collaborators
Zhejiang University School of Medicine, Obstetrics and Gynecology Hospital, Nutricia Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medical Nutrition Therapy, Gestational Diabetes Mellitus, Adverse Pregnancy Outcomes, Fasting Plasma Glucose, HbA1c, Gestational Weight Gain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TPF-DM Combined with Medical Nutrition Therapy Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Medical Nutrition Therapy Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Enteral Nutrition Suspension (TFP-DM)
Intervention Description
Individualized dietary and lifestyle intervention combined with the recommendation of Enteral Nutrition Suspension (TPF-DM, Diason 0.75 kcal/ml)
Intervention Type
Behavioral
Intervention Name(s)
Medical Nutrition Therpay
Intervention Description
Individualized dietary and lifestyle intervention
Primary Outcome Measure Information:
Title
Change in HbA1c from Baseline at 2 months
Time Frame
Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery
Title
Insulin treatmeant ratio
Time Frame
From enrollment to delivery
Title
Change in serum glycated albumin from Baseline at 2 months
Time Frame
Gestational age 24-28weeks and 32-34weeks and 36-40 weeks and 42-70days after delivery
Title
Change in fasting blood glucose concentration from Baseline at 2 months
Time Frame
Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery
Title
Change in Fasting insulin concentration from Baseline at 2 months
Time Frame
Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery
Secondary Outcome Measure Information:
Title
Oral glucose tolerance test
Time Frame
Gestational age 24-28 weeks and 42-70 days after delivery
Title
The insulin sensitivity (HOMA-IS)
Time Frame
From enrollment to the 42 days after delivery
Title
Gestational weight gain
Time Frame
From enrollment to the 42 days after delivery
Title
The incidence of macrosomia infants
Time Frame
From enrollment to delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zheng, PhD
Phone
86-13811830756
Email
yutian84@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guanghui Li, MD, PhD
Phone
86-13124728821
Email
liguanghui2007@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guanghui Li, MD, PhD
Organizational Affiliation
Beijing Obstetrics and Gynecology Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
City
Beijing
ZIP/Postal Code
100026
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanghui Li, MD, PhD
Phone
86-10-52273110
Email
liguanghui2007@163.com

12. IPD Sharing Statement

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

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