Medical Nutrition TherapyNCT03957603
Medical Nutrition Therapy Combined With TPF-DM in Pregnant Women With Gestational Diabetes Mellitus
A study testing Enteral Nutrition Suspension (TFP-DM) and Medical Nutrition Therpay in people with Medical Nutrition Therapy and Gestational Diabetes Mellitus, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Medical Nutrition Therapy, Gestational Diabetes Mellitus, Adverse Pregnancy Outcomes
- What is being tested?
- Enteral Nutrition Suspension (TFP-DM) and Medical Nutrition Therpay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, 100026
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Medical Nutrition Therapy, Gestational Diabetes Mellitus, Adverse Pregnancy Outcomes, Fasting Plasma Glucose, HbA1c, Gestational Weight Gain
- Being tested
- Enteral Nutrition Suspension (TFP-DM), Medical Nutrition Therpay
- Medical subject headings
- Diabetes, Gestational, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Medical Nutrition TherpayBehavioural
Individualized dietary and lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Enteral Nutrition Suspension (TFP-DM) |
| 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. Receives: Behavioral: Medical Nutrition Therpay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from Baseline at 2 months
Measured: Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery
Insulin treatmeant ratio
Measured: From enrollment to delivery
Change in serum glycated albumin from Baseline at 2 months
Measured: 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
Measured: 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
Measured: Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery
Secondary outcomes (4)
Oral glucose tolerance test
Measured: Gestational age 24-28 weeks and 42-70 days after delivery
The insulin sensitivity (HOMA-IS)
Measured: From enrollment to the 42 days after delivery
Gestational weight gain
Measured: From enrollment to the 42 days after delivery
The incidence of macrosomia infants
Measured: From enrollment to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start16 May 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medical Nutrition TherapyStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, Nutricia Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Guanghui Li, Capital Medical University
- Investigators
- Guanghui Li, MD, PhD, Principal investigator, Beijing Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957603
- Sponsor's protocol ID
- 2017-KY-061-01
- Status last verified
- Mar 2024
- First submitted
- 14 May 2019
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39536397
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03957603
- Acronym / sponsor ID
- 2017-KY-061-01
- Conditions
- Medical Nutrition Therapy, Gestational Diabetes Mellitus, Adverse Pregnancy Outcomes, Fasting Plasma Glucose, HbA1c, Gestational Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, Nutricia Pharmaceutical Co., Ltd.
- Study start
- 16 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPF-DM Combined with Medical Nutrition Therapy Intervention | Experimental | Dietary Supplement: Enteral Nutrition Suspension (TFP-DM)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 | Behavioral: Medical Nutrition TherpayBased 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Dietary supplement | TPF-DM Combined with Medical Nutrition Therapy Intervention |
| Medical Nutrition TherpayIndividualized dietary and lifestyle intervention | Behavioural | Medical Nutrition Therapy Intervention |
Primary outcome
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
Insulin treatmeant ratio
Time frame: From enrollment to delivery
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
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
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
4 secondary outcomes
Oral glucose tolerance test
Time frame: Gestational age 24-28 weeks and 42-70 days after delivery
The insulin sensitivity (HOMA-IS)
Time frame: From enrollment to the 42 days after delivery
Gestational weight gain
Time frame: From enrollment to the 42 days after delivery
The incidence of macrosomia infants
Time frame: From enrollment to delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 39536397Yang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guanghui Li, MD, PhD principal investigator
Beijing Obstetrics and Gynecology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral Nutrition Suspension (TFP-DM) and Medical Nutrition Therpay in people with Medical Nutrition Therapy and Gestational Diabetes Mellitus, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03957603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.