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RecruitingNCT06335225Updated Mar 28, 2024

Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics

An interventional study of Precise nutritional intervention and Conventional nutritional intervention in Prediabetes, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Prediabetes

Keywords

  • Prediabetes
  • Nutrigenomics
  • Nutritional intervention
03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's planned enrollment of 60 is close to the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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%.
  2. 18 ≤ Age \<70.

Exclusion criteria

Exclusion Criteria:

  1. Patients who can be diagnosed with diabetes mellitus.
  2. Patients applying antidiabetic drugs, glucocorticoids, and other drugs that have an effect on blood glucose.
  3. Females during pregnancy or lactation.
  4. Patients with gastrointestinal disorders, psychiatric disorders, autoimmune disorders, tumors, etc.
  5. Patients with acute cardiovascular and (or) cerebrovascular diseases within 6 months prior to study participation.
  6. 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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Precise nutrition group

    Behavioral: Precise nutritional intervention

  • Active comparator
    Control group

    Behavioral: Conventional nutritional intervention

Interventions

  • BehavioralPrecise nutritional intervention

    Diabetic precision nutrition prescription based on the results of nutrigenomics.

  • BehavioralConventional nutritional intervention

    Conventional diabetes nutrition prescription.

06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: week 0, week 12, week 24

Secondary outcomes

  1. Concentration of fasting plasma glucose

    Time frame: week 0, week 12, week 24

  2. Concentration of 2-hour plasma glucose

    Time frame: week 0, week 24

  3. Concentration of fasting insulin

    Time frame: week 0, week 12, week 24

  4. Concentration of fasting C peptide

    Time frame: week 0, week 12, week 24

  5. Concentration of TC, TG, LDL-C, and HDL-C

    Time frame: week 0, week 12, week 24

  6. Concentration of ALT, AST, TBIL

    Time frame: week 0, week 12, week 24

  7. Concentration of creatinine

    Time frame: week 0, week 12, week 24

  8. BMI

    BMI (kg/m\^2) =body weight/(height)\^2

    Time frame: week 0, week 4, week 8, week 12, week 16, week 20, week 24

  9. Waist hip ratio

    Waist hip ratio = waist circumference/hip circumference

    Time frame: week 0, week 4, week 8, week 12, week 16, week 20, week 24

07

Study locations

1 of 1 sites recruiting
  • China-Japan Friendship Hospital
    Beijing, China
    • Xiao Ma, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06335225
Lead sponsor
China-Japan Friendship Hospital
Responsible party
Ma Xiao (Director of health examination center department, China-Japan Friendship Hospital) — Principal investigator
First posted
Mar 28, 2024
Start date
Mar 13, 2024
Primary completion
Jul 31, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Mar 28, 2024

Study contacts

Xiao Ma, MD
Contact
redapple3155@qq.com
13621142939

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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