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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Medical Nutrition Therapy Combined With TPF-DM in Pregnant Women With Gestational Diabetes Mellitus on Blood Glucose Fluctuations and Pregnancy Outcomes

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

Intervention / Treatment
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* Dietary Supplement: Enteral Nutrition Suspension (TFP-DM)
* Behavioral: Medical Nutrition Therpay


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPF-DM Combined with Medical Nutrition Therapy Intervention<br>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)<br>* Individualized dietary and lifestyle intervention combined with the recommendation of Enteral Nutrition Suspension (TPF-DM, Diason 0.75 kcal/ml)<br>|
| Active Comparator: Medical Nutrition Therapy Intervention<br>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<br>* Individualized dietary and lifestyle intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |