Clinical trial NCT06335225: Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics
Official title: Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes
Keywords: Prediabetes
Nutrigenomics
Nutritional intervention
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

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).

Primary outcomes:
measure: HbA1c
timeFrame: week 0, week 12, week 24
Secondary outcomes:
measure: Concentration of fasting plasma glucose
timeFrame: week 0, week 12, week 24
measure: Concentration of 2-hour plasma glucose
timeFrame: week 0, week 24
measure: Concentration of fasting insulin
timeFrame: week 0, week 12, week 24
measure: Concentration of fasting C peptide
timeFrame: week 0, week 12, week 24
measure: Concentration of TC, TG, LDL-C, and HDL-C
timeFrame: week 0, week 12, week 24
measure: Concentration of ALT, AST, TBIL
timeFrame: week 0, week 12, week 24
measure: Concentration of creatinine
timeFrame: week 0, week 12, week 24
measure: BMI
timeFrame: week 0, week 4, week 8, week 12, week 16, week 20, week 24
measure: Waist hip ratio
timeFrame: week 0, week 4, week 8, week 12, week 16, week 20, week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
References: