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

Not Applicable

Recruiting

• Conditions: Prediabetes
• Interventions: Behavioral: Precise nutritional intervention; Behavioral: Conventional nutritional intervention

• Registration Number: NCT06335225
• Lead Sponsor: China-Japan Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-13
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Precise nutrition group	Precise nutritional intervention	-
Control group	Conventional nutritional intervention	-

Primary Outcome Measures

Name	Time	Method
HbA1c	week 0, week 12, week 24

Secondary Outcome Measures

Name	Time	Method
Concentration of fasting plasma glucose	week 0, week 12, week 24
Concentration of fasting insulin	week 0, week 12, week 24
Concentration of TC, TG, LDL-C, and HDL-C	week 0, week 12, week 24
Concentration of creatinine	week 0, week 12, week 24
Waist hip ratio	week 0, week 4, week 8, week 12, week 16, week 20, week 24	Waist hip ratio = waist circumference/hip circumference
Concentration of 2-hour plasma glucose	week 0, week 24
Concentration of ALT, AST, TBIL	week 0, week 12, week 24
Concentration of fasting C peptide	week 0, week 12, week 24
BMI	week 0, week 4, week 8, week 12, week 16, week 20, week 24	BMI (kg/m\^2) =body weight/(height)\^2

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China