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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Precise nutrition group

Group Type EXPERIMENTAL

Precise nutritional intervention

Intervention Type BEHAVIORAL

Diabetic precision nutrition prescription based on the results of nutrigenomics.

Control group

Group Type ACTIVE_COMPARATOR

Conventional nutritional intervention

Intervention Type BEHAVIORAL

Conventional diabetes nutrition prescription.

Interventions

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Precise nutritional intervention

Diabetic precision nutrition prescription based on the results of nutrigenomics.

Intervention Type BEHAVIORAL

Conventional nutritional intervention

Conventional diabetes nutrition prescription.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No