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| Name | Class |
|---|---|
| Zhejiang University School of Medicine, Obstetrics and Gynecology Hospital | UNKNOWN |
| Nutricia Pharmaceutical Co., Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guanghui Li, MD, PhD | Beijing Obstetrics and Gynecology Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Obstetrics and Gynecology Hospital,Capital Medical University | Beijing | 100026 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39536397 | Derived | 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. |
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| Medical Nutrition Therpay | Behavioral | Individualized dietary and lifestyle intervention |
|
| Gestational weight gain |
| From enrollment to the 42 days after delivery |
| The incidence of macrosomia infants | From enrollment to delivery |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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