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

Prediabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335225
• Other study ID #: 2023-NHLHCRF-YXHZ-ZRMS-06
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: China-Japan Friendship Hospital
• Contact: Xiao Ma, MD
• Phone: 13621142939
• Email: redapple3155[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State

Intervention

Behavioral:
• Precise nutritional intervention
Diabetic precision nutrition prescription based on the results of nutrigenomics.
• Conventional nutritional intervention
Conventional diabetes nutrition prescription.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		week 0, week 12, week 24
Secondary	Concentration of fasting plasma glucose		week 0, week 12, week 24
Secondary	Concentration of 2-hour plasma glucose		week 0, week 24
Secondary	Concentration of fasting insulin		week 0, week 12, week 24
Secondary	Concentration of fasting C peptide		week 0, week 12, week 24
Secondary	Concentration of TC, TG, LDL-C, and HDL-C		week 0, week 12, week 24
Secondary	Concentration of ALT, AST, TBIL		week 0, week 12, week 24
Secondary	Concentration of creatinine		week 0, week 12, week 24
Secondary	BMI	BMI (kg/m^2) =body weight/(height)^2	week 0, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Waist hip ratio	Waist hip ratio = waist circumference/hip circumference	week 0, week 4, week 8, week 12, week 16, week 20, week 24