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

NCT ID: NCT04368741

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2020-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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SANZ®KINGWILL Combined With CGM Equipment in GDM Patients GLUCERNA SR® Combined With CGM Equipment in GDM Patients

Keywords

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nutrition product continuous glucose monitoring gestational diabetes mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

SANZ®KINGWILL

Group Type EXPERIMENTAL

SANZ®KINGWILL

Intervention Type DIETARY_SUPPLEMENT

20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively.

Control group

GLUCERNA SR®

Group Type OTHER

GLUCERNA SR®

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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SANZ®KINGWILL

20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively.

Intervention Type DIETARY_SUPPLEMENT

GLUCERNA SR®

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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San MediTech(Huzhou)Co.,Ltd.

UNKNOWN

Sponsor Role collaborator

Sanz Pharmaceutical Group

UNKNOWN

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shuli He, attending

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liangkun Ma, doctor

Role: CONTACT

Phone: 13021961166

Email: [email protected]

Feiling Huang, master

Role: CONTACT

Phone: 18510875983

Email: [email protected]

Facility Contacts

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Liangkun Ma, doctor

Role: primary

Feiling Huang, master

Role: backup

Other Identifiers

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ZS-2103

Identifier Type: -

Identifier Source: org_study_id