PrediabetesNCT06335225
Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics
A study testing Precise nutritional intervention and Conventional nutritional intervention in people with Prediabetes, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
With the aging of population and the change of lifestyle, the prevalence of prediabetes is increasing year by year. Nutritional factors are one of the important environmental factors in the occurrence and development of abnormal glucose metabolism. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Precise nutritional intervention and Conventional nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2024to 31 Jul 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OGTT: 6.1 mmol/L ≤ fasting plasma glucose < 7.0 mmol/L and（or）7.8 mmol/L ≤ 2 hour plasma glucose < 11.1 mmol/L and (or) 5.7% ≤ HbA1c< 6.5%.
- 18 ≤ Age <70.
Who cannot join
- Patients who can be diagnosed with diabetes mellitus.
- Patients applying antidiabetic drugs, glucocorticoids, and other drugs that have an effect on blood glucose.
- Females during pregnancy or lactation.
- Patients with gastrointestinal disorders, psychiatric disorders, autoimmune disorders, tumors, etc.
- Patients with acute cardiovascular and (or) cerebrovascular diseases within 6 months prior to study participation.
- Patients with hepatic dysfunction (ALT, AST, or total bilirubin ≥ 2 times the upper limit of normal), renal dysfunction (creatinine > the upper limit of normal), and cardiac dysfunction (NYHA class III and IV).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
Xiao Ma, MD
About this study
With the aging of population and the change of lifestyle, the prevalence of prediabetes is increasing year by year. Nutritional factors are one of the important environmental factors in the occurrence and development of abnormal glucose metabolism. The medical nutritional treatment of diabetes is recommended as the cornerstone of diabetes treatment by various guidelines. With the development of nutrigenomics, it has been found that genes related to the absorption, metabolism, distribution and excretion of various nutrients are related to diabetes. This study intends to conduct precision nutrition intervention for prediabetic patients based on nutritional genes, and evaluate the effectiveness and safety of these nutritional interventions.
- Conditions
- Prediabetes
- Being tested
- Precise nutritional intervention, Conventional nutritional intervention
- Keywords
- Prediabetes, Nutrigenomics, Nutritional intervention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precise nutritional interventionBehavioural
Diabetic precision nutrition prescription based on the results of nutrigenomics.
Conventional nutritional interventionBehavioural
Conventional diabetes nutrition prescription.
| Study group | Role | What they receive |
|---|---|---|
| Precise nutrition group | Experimental | Not described Receives: Behavioral: Precise nutritional intervention |
| Control group | Active comparator | Not described Receives: Behavioral: Conventional nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: week 0, week 12, week 24
Secondary outcomes (9)
Concentration of fasting plasma glucose
Measured: week 0, week 12, week 24
Concentration of 2-hour plasma glucose
Measured: week 0, week 24
Concentration of fasting insulin
Measured: week 0, week 12, week 24
Concentration of fasting C peptide
Measured: week 0, week 12, week 24
Concentration of TC, TG, LDL-C, and HDL-C
Measured: week 0, week 12, week 24
Concentration of ALT, AST, TBIL
Measured: week 0, week 12, week 24
Concentration of creatinine
Measured: week 0, week 12, week 24
BMI
BMI (kg/m^2) =body weight/(height)^2
Measured: week 0, week 4, week 8, week 12, week 16, week 20, week 24
Waist hip ratio
Waist hip ratio = waist circumference/hip circumference
Measured: week 0, week 4, week 8, week 12, week 16, week 20, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start13 Mar 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Xiao, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335225
- Sponsor's protocol ID
- 2023-NHLHCRF-YXHZ-ZRMS-06
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics
- ClinicalTrials.gov ID
- NCT06335225
- Acronym / sponsor ID
- 2023-NHLHCRF-YXHZ-ZRMS-06
- Conditions
- Prediabetes
- Keywords
- Prediabetes, Nutrigenomics, Nutritional intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 28 Mar 2024 (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.
With the aging of population and the change of lifestyle, the prevalence of prediabetes is increasing year by year. Nutritional factors are one of the important environmental factors in the occurrence and development of abnormal glucose metabolism. The medical nutritional treatment of diabetes is recommended as the cornerstone of diabetes treatment by various guidelines. With the development of nutrigenomics, it has been found that genes related to the absorption, metabolism, distribution and excretion of various nutrients are related to diabetes. This study intends to conduct precision nutrition intervention for prediabetic patients based on nutritional genes, and evaluate the effectiveness and safety of these nutritional interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precise nutrition group | Experimental | Behavioral: Precise nutritional intervention |
| Control group | Active comparator | Behavioral: Conventional nutritional intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OGTT: 6.1 mmol/L ≤ fasting plasma glucose < 7.0 mmol/L and（or）7.8 mmol/L ≤ 2 hour plasma glucose < 11.1 mmol/L and (or) 5.7% ≤ HbA1c< 6.5%.
- 18 ≤ Age <70.
Key exclusion criteria (6 listed)
- Patients who can be diagnosed with diabetes mellitus.
- Patients applying antidiabetic drugs, glucocorticoids, and other drugs that have an effect on blood glucose.
- Females during pregnancy or lactation.
- Patients with gastrointestinal disorders, psychiatric disorders, autoimmune disorders, tumors, etc.
- Patients with acute cardiovascular and (or) cerebrovascular diseases within 6 months prior to study participation.
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 |
|---|---|---|
| Precise nutritional interventionDiabetic precision nutrition prescription based on the results of nutrigenomics. | Behavioural | Precise nutrition group |
| Conventional nutritional interventionConventional diabetes nutrition prescription. | Behavioural | Control group |
Primary outcome
HbA1c
Time frame: week 0, week 12, week 24
9 secondary outcomes
Concentration of fasting plasma glucose
Time frame: week 0, week 12, week 24
Concentration of 2-hour plasma glucose
Time frame: week 0, week 24
Concentration of fasting insulin
Time frame: week 0, week 12, week 24
Concentration of fasting C peptide
Time frame: week 0, week 12, week 24
Concentration of TC, TG, LDL-C, and HDL-C
Time frame: week 0, week 12, week 24
Concentration of ALT, AST, TBIL
Time frame: week 0, week 12, week 24
Concentration of creatinine
Time frame: week 0, week 12, week 24
BMI
Time frame: week 0, week 4, week 8, week 12, week 16, week 20, week 24
Waist hip ratio
Time frame: week 0, week 4, week 8, week 12, week 16, week 20, week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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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 Precise nutritional intervention and Conventional nutritional intervention in people with Prediabetes, run by China-Japan Friendship 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 2 inclusion and 6 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 28 Mar 2024. 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 Xiao Ma, MD (13621142939, redapple3155@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: week 0, week 12, week 24). 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 28 Mar 2024.