Type 2 DiabetesNCT04266171
Precision Nutrition Counseling in Type 2 Diabetes Patients
A study testing Diet education based on CGMS data and Conventional diet education in people with Type 2 Diabetes, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the effect of precision nutrition education using continuous glucose monitoring system (CGMS) in longterm glycemic control in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diet education based on CGMS data and Conventional diet education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jan 2020to 31 Dec 2021
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients (Fasting blood glucose ≥ 126 mg/dl or HbA1c ≥ 6.5% or Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin)
- HbA1c 6.5%~10%
- Body weight change less than 5% in 3 month
- Subjects who agreed to the study protocol
Who cannot join
- Type 1 diabetes patients
- Subjects using insulin other than basal insulin
- Subjects who have newly started or have changed anti diabetic drugs within 3 months
- Subjects who have been received diabetes diet education within 6 months
- Females who are pregnant or doing breast feeding
- Subjects with alcohol addiction or drug abuse
Show all 12Show fewer
- Subjects who are using drugs that can influence blood glucose levels (e.g. steroid)
- Subjects who are currently using acetaminophen or who should use acetaminophen during CGMS attach period
- Subjects who have skin problems on CGMS sensor insertion site (e.g. burn, excessive body hair, inflammation, rash, tattoo)
- Subjects who have newly started, changed, or stoped probiotics or prebiotics within 2 weeks
- Subjects who have used antibiotics (oral or intravenous) within 2 weeks
- In addition, if it falls under the exclusion criteria according to researchers discretion
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Sun Joon Moon, MD, 82-2-2072-1471, ipleat.m@gmail.com
Young Min Cho, MD, PhD, 82-2-2072-1965, ymchomd@snu.ac.kr
About this study
Official title: Development of Precision Nutrition Counseling in Type 2 Diabetes Patients: Using Continuous Glucose Monitoring System
The aim of this study is to evaluate the effect of precision nutrition education using continuous glucose monitoring system (CGMS) in longterm glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who received diet education using CGMS will be compared to those in subjects who received conventional diet education.
Read the detailed description
Fifty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are CGMS education group and conventional education group. The study will be conducted for 12 weeks for each participants. Intervention group will receive diet education based on CGMS data, using post prandial glucose response, calculated by incremental area under curve of glucose level. Control group will receive conventional diabetes diet education without CGMS data. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, homeostatic model assessment of insulin resistance (HOMA-IR) , c-peptide, microbiome, 7-point self monitoring of blood glucose (SMBG), and compliance/satisfaction questionnaire from baseline for 12 weeks.
- Conditions
- Type 2 Diabetes
- Being tested
- Diet education based on CGMS data, Conventional diet education
- Keywords
- continuous glucose monitor, diet education, Precision nutrition
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet education based on CGMS dataBehavioural
Intervention group will receive diet education based on CGMS data, using post prandial glucose response, calculated by incremental area under curve of glucose level. Control group will receive conventional diabetes diet education without CGMS data.
Conventional diet educationBehavioural
Control group will receive conventional diabetes diet education without CGMS data.
| Study group | Role | What they receive |
|---|---|---|
| CGMS Diet Education | Experimental | Not described Receives: Behavioral: Diet education based on CGMS data |
| Conventional Diet Education | Active comparator | Not described Receives: Behavioral: Conventional diet education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline
Measured: 0 week, 12 weeks
Secondary outcomes (11)
Change in fasting blood glucose level from baseline
Measured: 0 week, 12 weeks
Change in body weight from baseline
Measured: 0 week, 12 weeks
Change in waist circumference from baseline
Measured: 0 week, 12 weeks
Change in blood Triglyceride level from baseline
Measured: 0 week, 12 weeks
Change in blood High-density lipoprotein level from baseline
Measured: 0 week, 12 weeks
Change in blood Low-density lipoprotein level from baseline
Measured: 0 week, 12 weeks
Change in HOMA-IR from baseline
Measured: 0 week, 12 weeks
Change in c-peptide from baseline
Measured: 0 week, 12 weeks
Change in microbiome profile from baseline
Change in the diversity index of the gut microbiota, change in the compositions of the gut microbiota
Measured: 0 week, 12 weeks
Change in 7-point SMBG from baseline
Measured: 0 week, 12 weeks
Compliance/Satisfaction Questionnaire
Change in dietary habits, self-efficacy of diet management , and satisfaction with the education
Measured: 0 week, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start16 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ChunLab
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266171
- Sponsor's protocol ID
- H-1911-059-1078
- Status last verified
- Jan 2020
- First submitted
- 2 Feb 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- 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 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Precision Nutrition Counseling in Type 2 Diabetes Patients: Using Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT04266171
- Acronym / sponsor ID
- H-1911-059-1078
- Conditions
- Type 2 Diabetes
- Keywords
- continuous glucose monitor, diet education, Precision nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- ChunLab
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 12 Feb 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.
The aim of this study is to evaluate the effect of precision nutrition education using continuous glucose monitoring system (CGMS) in longterm glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who received diet education using CGMS will be compared to those in subjects who received conventional diet education.
Detailed description
Fifty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are CGMS education group and conventional education group. The study will be conducted for 12 weeks for each participants. Intervention group will receive diet education based on CGMS data, using post prandial glucose response, calculated by incremental area under curve of glucose level. Control group will receive conventional diabetes diet education without CGMS data. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, homeostatic model assessment of insulin resistance (HOMA-IR) , c-peptide, microbiome, 7-point self monitoring of blood glucose (SMBG), and compliance/satisfaction questionnaire from baseline for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGMS Diet Education | Experimental | Behavioral: Diet education based on CGMS data |
| Conventional Diet Education | Active comparator | Behavioral: Conventional diet education |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes patients (Fasting blood glucose ≥ 126 mg/dl or HbA1c ≥ 6.5% or Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin)
- HbA1c 6.5%~10%
- Body weight change less than 5% in 3 month
- Subjects who agreed to the study protocol
Key exclusion criteria (12 listed)
- Type 1 diabetes patients
- Subjects using insulin other than basal insulin
- Subjects who have newly started or have changed anti diabetic drugs within 3 months
- Subjects who have been received diabetes diet education within 6 months
- Females who are pregnant or doing breast feeding
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 |
|---|---|---|
| Diet education based on CGMS dataIntervention group will receive diet education based on CGMS data, using post prandial glucose response, calculated by incremental area under curve of glucose level. Control group will receive conventional diabetes diet education without CGMS data. | Behavioural | CGMS Diet Education |
| Conventional diet educationControl group will receive conventional diabetes diet education without CGMS data. | Behavioural | Conventional Diet Education |
Primary outcome
Change in HbA1c from baseline
Time frame: 0 week, 12 weeks
11 secondary outcomes
Change in fasting blood glucose level from baseline
Time frame: 0 week, 12 weeks
Change in body weight from baseline
Time frame: 0 week, 12 weeks
Change in waist circumference from baseline
Time frame: 0 week, 12 weeks
Change in blood Triglyceride level from baseline
Time frame: 0 week, 12 weeks
Change in blood High-density lipoprotein level from baseline
Time frame: 0 week, 12 weeks
Change in blood Low-density lipoprotein level from baseline
Time frame: 0 week, 12 weeks
Change in HOMA-IR from baseline
Time frame: 0 week, 12 weeks
Change in c-peptide from baseline
Time frame: 0 week, 12 weeks
Change in microbiome profile from baseline
Time frame: 0 week, 12 weeks
Change in 7-point SMBG from baseline
Time frame: 0 week, 12 weeks
Compliance/Satisfaction Questionnaire
Time frame: 0 week, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet education based on CGMS data and Conventional diet education in people with Type 2 Diabetes, run by Seoul National University Hospital at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 12 Feb 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from baseline (time frame: 0 week, 12 weeks). 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 12 Feb 2020.