NCT04368741

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 30, 2020

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

December 1, 2019

Last Update Submit

April 29, 2020

Conditions

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

Keywords

nutrition productcontinuous glucose monitoringgestational diabetes mellitus

Outcome Measures

Primary Outcomes (5)

  • Number of other product-related/possibly related adverse events or serious adverse events

    Number of other product-related/possibly related adverse events or serious adverse events

    4 weeks

  • Changes of Weight

    4 weeks

  • Area under the blood glucose curve (AUC)

    Area under the blood glucose curve (AUC) by CGM within 2 hours of using the nutrition product.

    4 weeks

  • Blood glucose control outcome

    Fasting blood glucose

    4 weeks

  • Glycated albumin level

    4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

SANZ®KINGWILL

Dietary Supplement: SANZ®KINGWILL

Control group

OTHER

GLUCERNA SR®

Dietary Supplement: GLUCERNA SR®

Interventions

SANZ®KINGWILLDIETARY_SUPPLEMENT

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

Experimental group
GLUCERNA SR®DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

Age22 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • \. 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.
  • \. Patients with severe heart, liver, kidney dysfunction, mental retardation, dyscrasia, etc.
  • \. Patients who cannot tolerate enteral nutrition. 6. Patients with other conditions which investigator believes they are not eligible for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucerna

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Shuli He, attending

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangkun Ma, doctor

CONTACT

13021961166maliangkun@pumch.cn

Feiling Huang, master

CONTACT

18510875983huangfeiling_13@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2019

First Posted

April 30, 2020

Study Start

October 15, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

April 30, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)