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

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ClinicalTrials.gov Identifier: NCT03957603
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborators:
Zhejiang University School of Medicine, Obstetrics and Gynecology Hospital
Nutricia Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Guanghui Li, Capital Medical University

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.


Condition or disease Intervention/treatment Phase
Medical Nutrition Therapy Gestational Diabetes Mellitus Adverse Pregnancy Outcomes Fasting Plasma Glucose HbA1c Gestational Weight Gain Dietary Supplement: Enteral Nutrition Suspension (TFP-DM) Behavioral: Medical Nutrition Therpay Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 16, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: 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)

Active Comparator: 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.
Behavioral: Medical Nutrition Therpay
Individualized dietary and lifestyle intervention




Primary Outcome Measures :
  1. 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 ]
  2. Insulin treatmeant ratio [ Time Frame: From enrollment to delivery ]
  3. 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 ]
  4. 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 ]
  5. 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 Measures :
  1. Oral glucose tolerance test [ Time Frame: Gestational age 24-28 weeks and 42-70 days after delivery ]
  2. The insulin sensitivity (HOMA-IS) [ Time Frame: From enrollment to the 42 days after delivery ]
  3. Gestational weight gain [ Time Frame: From enrollment to the 42 days after delivery ]
  4. The incidence of macrosomia infants [ Time Frame: From enrollment to delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957603


Contacts
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Contact: Wei Zheng, PhD 86-13811830756 yutian84@126.com
Contact: Guanghui Li, MD, PhD 86-13124728821 liguanghui2007@163.com

Locations
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China
Beijing Obstetrics and Gynecology Hospital,Capital Medical University Recruiting
Beijing, China, 100026
Contact: Guanghui Li, MD, PhD    86-10-52273110    liguanghui2007@163.com   
Sponsors and Collaborators
Capital Medical University
Zhejiang University School of Medicine, Obstetrics and Gynecology Hospital
Nutricia Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Guanghui Li, MD, PhD Beijing Obstetrics and Gynecology Hospital

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Responsible Party: Guanghui Li, Professor, MD, PhD, Capital Medical University
ClinicalTrials.gov Identifier: NCT03957603     History of Changes
Other Study ID Numbers: 2017-KY-061-01
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes, Gestational
Weight Gain
Gestational Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Body Weight Changes
Body Weight
Signs and Symptoms