Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prediabetes
- Sponsor
- China-Japan Friendship Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- HbA1c
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ma Xiao
Director of health examination center department
China-Japan Friendship Hospital
Eligibility Criteria
Inclusion Criteria
- •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%.
- •18 ≤ Age \<70.
Exclusion Criteria
- •Patients who can be diagnosed with diabetes mellitus.
- •Patients applying antidiabetic drugs, glucocorticoids, and other drugs that have an effect on blood glucose.
- •Females during pregnancy or lactation.
- •Patients with gastrointestinal disorders, psychiatric disorders, autoimmune disorders, tumors, etc.
- •Patients with acute cardiovascular and (or) cerebrovascular diseases within 6 months prior to study participation.
- •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).
Outcomes
Primary Outcomes
HbA1c
Time Frame: week 0, week 12, week 24
Secondary Outcomes
- Concentration of 2-hour plasma glucose(week 0, week 24)
- 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)
- 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)