Medical Nutrition Therapy Combined With TPF-DM in Pregnant Women With Gestational Diabetes Mellitus (NCT03957603) | Clinical Trial Compass
CompletedNot Applicable
Medical Nutrition Therapy Combined With TPF-DM in Pregnant Women With Gestational Diabetes Mellitus
China100 participantsStarted 2019-05-16
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in HbA1c from Baseline at 2 months
Timeframe: Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery
2
Insulin treatmeant ratio
Timeframe: From enrollment to delivery
3
Change in serum glycated albumin from Baseline at 2 months
Timeframe: 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
Timeframe: 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
Timeframe: Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery