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Nutrition Product Combine With Continuous Glucose Monitoring in Gestational Diabetes Mellitus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368741
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborators:
San MediTech(Huzhou)Co.,Ltd.
Sanz Pharmaceutical Group
Beijing Chao Yang Hospital
Beijing Obstetrics and Gynecology Hospital
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
A prospective, multicenter, randomized controlled trial including about 60 Gestational Diabetes Mellitus patients (GDM) in Beijing will be included to evaluate the effectiveness and safety of nutrition product (SANZ®KINGWILL) in GDM patients, based on Continuous Glucose Monitoring (San MediTech CGM-303).

Condition or disease Intervention/treatment Phase
SANZ®KINGWILL Combined With CGM Equipment in GDM Patients GLUCERNA SR® Combined With CGM Equipment in GDM Patients Dietary Supplement: SANZ®KINGWILL Dietary Supplement: GLUCERNA SR® Not Applicable

Detailed Description:
This study will recruit pregnant women who were diagnosed as GDM by 75g Oral glucose tolerance test (OGTT) in 2nd trimester and followed up for 1month. A total of 60 GDM patients were expected to be enrolled. Using the double-blind method, they were randomly divided into two groups: experimental group and control group. Both of the two groups were provided medical nutrition treatment by nutritionist after GDM was diagnosed and CGM equipment (San MediTech CGM-303) was worn. Blood and urine samples were collected. At the following two days, oatmeal (SHIZHUANG) was used as extra meal at 10:00am and 15:00pm in both groups. In the next 4 weeks experimental group was provided with the domestic nutrition product (SANZ®KINGWILL), while existing products (GLUCERNA SR®) for control group as their extra meals at 10:00am and 15:00pm. In the last day, CGM equipment (San MediTech CGM-303) was removed and blood and urine samples were collected.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effectiveness and Safety of Nutrition Product in Gestational Diabetes Mellitus Patients, Based on Continuous Glucose Monitoring, a Prospective Randomized Controlled Trial
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
SANZ®KINGWILL
Dietary Supplement: SANZ®KINGWILL
20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively.

Control group
GLUCERNA SR®
Dietary Supplement: GLUCERNA SR®
17.5g nutrition product (GLUCERNA SR®) was used as extra meal at 10:00am and 15:00pm, respectively.




Primary Outcome Measures :
  1. Number of other product-related/possibly related adverse events or serious adverse events [ Time Frame: 4 weeks ]
    Number of other product-related/possibly related adverse events or serious adverse events

  2. Changes of Weight [ Time Frame: 4 weeks ]
  3. Area under the blood glucose curve (AUC) [ Time Frame: 4 weeks ]
    Area under the blood glucose curve (AUC) by CGM within 2 hours of using the nutrition product.

  4. Blood glucose control outcome [ Time Frame: 4 weeks ]
    Fasting blood glucose

  5. Glycated albumin level [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Women aged 22 to 40 years old 2. Diagnosed as gestational diabetes mellitus 3. Signed informed consent

Exclusion Criteria:

  • 1. GDM patient who is no longer suitable to continue pregnancy. 2. Patients who use any hypoglycemic drugs or any type of similar products. 3. Patients who have diseases severely affected the nutrition product digestion and absorption.

    4. Patients with severe heart, liver, kidney dysfunction, mental retardation, dyscrasia, etc.

    5. Patients who cannot tolerate enteral nutrition. 6. Patients with other conditions which investigator believes they are not eligible for this study.


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): NCT04368741


Contacts
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Contact: Liangkun Ma, doctor 13021961166 maliangkun@pumch.cn
Contact: Feiling Huang, master 18510875983 huangfeiling_13@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Liangkun Ma, doctor    +8613021961166    maliangkun@pumch.cn   
Contact: Feiling Huang, master    +8618510875983    huangfeiling_13@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
San MediTech(Huzhou)Co.,Ltd.
Sanz Pharmaceutical Group
Beijing Chao Yang Hospital
Beijing Obstetrics and Gynecology Hospital
Investigators
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Principal Investigator: Shuli He, attending Peking Union Medical College Hospital
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04368741    
Other Study ID Numbers: ZS-2103
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
nutrition product
continuous glucose monitoring
gestational diabetes mellitus
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications