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

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.

Study Overview

• Status: Recruiting
• Conditions: Prediabetes
• Intervention / Treatment: Behavioral: Precise nutritional intervention; Behavioral: Conventional nutritional intervention

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiao Ma, MD; Phone Number: 13621142939; Email: redapple3155@qq.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: Xiao Ma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Behavioral: Conventional nutritional intervention; Conventional diabetes nutrition prescription.
Experimental: Precise nutrition group	Behavioral: Precise nutritional intervention; Diabetic precision nutrition prescription based on the results of nutrigenomics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c	week 0, week 12, week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of fasting plasma glucose		week 0, week 12, week 24
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 ALT, AST, TBIL		week 0, week 12, week 24
Concentration of creatinine		week 0, week 12, week 24
BMI	BMI (kg/m^2) =body weight/(height)^2	week 0, week 4, week 8, week 12, week 16, week 20, week 24
Waist hip ratio	Waist hip ratio = waist circumference/hip circumference	week 0, week 4, week 8, week 12, week 16, week 20, week 24

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Prediabetes; Nutritional intervention; Nutrigenomics
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 2023-NHLHCRF-YXHZ-ZRMS-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No