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

NCT06335225 | Recruiting

• 1 other identifier: 2023-NHLHCRF-YXHZ-ZRMS-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes

Keywords

Prediabetes; Nutrigenomics; Nutritional intervention

Outcome Measures

Primary Outcomes (1)

• HbA1c

  week 0, week 12, week 24

Secondary Outcomes (9)

• 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

Study Arms (2)

Precise nutrition group

EXPERIMENTAL

Behavioral: Precise nutritional intervention

Control group

ACTIVE COMPARATOR

Behavioral: Conventional nutritional intervention

Interventions

Precise nutritional intervention BEHAVIORAL

Diabetic precision nutrition prescription based on the results of nutrigenomics.

Precise nutrition group

Conventional nutritional intervention BEHAVIORAL

Conventional diabetes nutrition prescription.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.
• ≤ Age \<70.

You may not qualify if:

• 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).

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Xiao Ma, MD

CONTACT

13621142939; redapple3155@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of health examination center department

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 28, 2024
• Study Start: March 13, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

CN (1)