Prediabetes
Conditions
Keywords
Prediabetes, Nutrigenomics, Nutritional intervention
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.
Interventions
BEHAVIORALPrecise nutritional intervention
Diabetic precision nutrition prescription based on the results of nutrigenomics.
BEHAVIORALConventional nutritional intervention
Conventional diabetes nutrition prescription.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | week 0, week 12, week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of 2-hour plasma glucose | week 0, week 24 | — |
| Concentration of fasting insulin | week 0, week 12, week 24 | — |
| Concentration of fasting C peptide | week 0, week 12, week 24 | — |
| Concentration of TC, TG, LDL-C, and HDL-C | week 0, week 12, week 24 | — |
| Concentration of fasting plasma glucose | week 0, week 12, week 24 | — |
| Concentration of creatinine | 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 |
| 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 ALT, AST, TBIL | week 0, week 12, week 24 | — |
Countries
China
Contacts
Primary ContactXiao Ma, MD
Outcome results
None listed