SANZ®KINGWILL Combined With CGM Equipment in GDM PatientsNCT04368741
Nutrition Product Combine With Continuous Glucose Monitoring in Gestational Diabetes Mellitus Patients
A study testing SANZ®KINGWILL and GLUCERNA SR® in people with SANZ®KINGWILL Combined With CGM Equipment in GDM Patients and GLUCERNA SR® Combined With CGM Equipment in GDM Patients, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 40 years, women only
- Conditions the study is for
- SANZ®KINGWILL Combined With CGM Equipment in GDM Patients, GLUCERNA SR® Combined With CGM Equipment in GDM Patients
- What is being tested?
- SANZ®KINGWILL and GLUCERNA SR®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2019to Oct 2020
- 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 22 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Women aged 22 to 40 years old 2. Diagnosed as gestational diabetes mellitus 3. Signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Liangkun Ma, doctor, +8613021961166, maliangkun@pumch.cn
Feiling Huang, master, +8618510875983, huangfeiling_13@163.com
About this study
Official title: Effectiveness and Safety of Nutrition Product in Gestational Diabetes Mellitus Patients, Based on Continuous Glucose Monitoring, a Prospective Randomized Controlled Trial
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).
Read the 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.
- Conditions
- SANZ®KINGWILL Combined With CGM Equipment in GDM Patients, GLUCERNA SR® Combined With CGM Equipment in GDM Patients
- Being tested
- SANZ®KINGWILL, GLUCERNA SR®
- Keywords
- nutrition product, continuous glucose monitoring, gestational diabetes mellitus
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANZ®KINGWILLDietary supplement
20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively.
GLUCERNA SR®Dietary supplement
17.5g nutrition product (GLUCERNA SR®) was used as extra meal at 10:00am and 15:00pm, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | SANZ®KINGWILL Receives: Dietary Supplement: SANZ®KINGWILL |
| Control group | Other | GLUCERNA SR® Receives: Dietary Supplement: GLUCERNA SR® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Changes of Weight
Measured: 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.
Measured: 4 weeks
Blood glucose control outcome
Fasting blood glucose
Measured: 4 weeks
Glycated albumin level
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start15 Oct 2019
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SANZ®KINGWILL Combined With CGM Equipment in GDM PatientsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- San MediTech(Huzhou)Co.,Ltd., Sanz Pharmaceutical Group, Beijing Chao Yang Hospital, Beijing Obstetrics and Gynecology Hospital
- Responsible party
- Sponsor
- Investigators
- Shuli He, attending, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368741
- Sponsor's protocol ID
- ZS-2103
- Status last verified
- Aug 2019
- First submitted
- 1 Dec 2019
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Nutrition Product in Gestational Diabetes Mellitus Patients, Based on Continuous Glucose Monitoring, a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04368741
- Acronym / sponsor ID
- ZS-2103
- Conditions
- SANZ®KINGWILL Combined With CGM Equipment in GDM Patients, GLUCERNA SR® Combined With CGM Equipment in GDM Patients
- Keywords
- nutrition product, continuous glucose monitoring, gestational diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- San MediTech(Huzhou)Co.,Ltd., Sanz Pharmaceutical Group, Beijing Chao Yang Hospital, Beijing Obstetrics and Gynecology Hospital
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 30 Apr 2020 (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.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: SANZ®KINGWILLSANZ®KINGWILL |
| Control group | Other | Dietary Supplement: GLUCERNA SR®GLUCERNA SR® |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Women aged 22 to 40 years old 2. Diagnosed as gestational diabetes mellitus 3. Signed informed consent
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| SANZ®KINGWILL20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively. | Dietary supplement | Experimental group |
| GLUCERNA SR®17.5g nutrition product (GLUCERNA SR®) was used as extra meal at 10:00am and 15:00pm, respectively. | Dietary supplement | Control group |
Primary outcome
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
Changes of Weight
Time frame: 4 weeks
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.
Blood glucose control outcome
Time frame: 4 weeks
Fasting blood glucose
Glycated albumin level
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Individual participant dataSharing planned: No
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.
Shuli He, attending principal investigator
Peking Union Medical College 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 SANZ®KINGWILL and GLUCERNA SR® in people with SANZ®KINGWILL Combined With CGM Equipment in GDM Patients and GLUCERNA SR® Combined With CGM Equipment in GDM Patients, run by Peking Union Medical College Hospital 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liangkun Ma, doctor (13021961166, maliangkun@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of other product-related/possibly related adverse events or serious adverse events (time frame: 4 weeks). 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?
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 30 Apr 2020.