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

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Prediabetes

Treatments: Behavioral: Conventional nutritional intervention; Behavioral: Precise nutritional intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06335225

2023-NHLHCRF-YXHZ-ZRMS-06

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Precise nutrition group

Experimental group

Treatment:

Behavioral: Precise nutritional intervention

Control group

Active Comparator group

Treatment:

Behavioral: Conventional nutritional intervention