Multi-omics Mechanisms of Lifestyle Intervention in Regulating Blood Glucose

Not Applicable

Not yet recruiting

• Conditions: Diabetes

• Registration Number: NCT07146308
• Lead Sponsor: Shanghai 6th People's Hospital

Brief Summary

The mechanisms by which lifestyle interventions regulate blood glucose remain incompletely understood. Traditional research has predominantly focused on single targets or pathways, making it difficult to comprehensively elucidate the complex biological regulatory networks. This study systematically investigates the effects of lifestyle interventions on blood glucose and explores their molecular mechanisms. Through integrated multi-omics analysis-including genomics, proteomics, metabolomics, and microbiomics-investigators aim to identify key biological pathways and molecular targets through which dietary, exercise, and other lifestyle interventions influence glucose regulation, as well as discover biomarkers that reflect the efficacy of these interventions. Building upon these findings, investigators will establish a multi-omics molecular network model linking lifestyle interventions to glucose regulation and develop an auxiliary decision-making system for personalised diabetes diagnosis and treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-13
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Study Start: 2025-08-31
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Aged 18-70 years

Exclusion Criteria

• Severe chronic diabetic complications or recent acute diabetic complications
• Type 1 diabetes mellitus
• Early-onset diabetes
• Patients currently using insulin therapy
• Recent severe hypoglycemic episodes
• Secondary obesity
• Pregnancy, severe hepatic/renal diseases, thyroid disorders, acute infections, psychiatric disorders, or other conditions that may interfere with study outcomes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Post-intervention incremental area under the glucose curve (iAUC) measured by continuous glucose monitoring (CGM)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR) Measured by Continuous Glucose Monitoring	Baseline and 4 weeks
Composite glucose metabolism profile	Baseline and 4 weeks	A composite outcome summarizing glucose metabolism indicators, including: HbA1c (%), Fasting plasma glucose (mmol/L), 60- and 120-minute plasma glucose during OGTT (mmol/L), Fasting and post-load insulin (μU/mL), Fasting and post-load C-peptide (ng/mL), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR, index), etc.
Composite kidney function profile	Baseline and 4 weeks	A composite outcome summarizing kidney function indicators, including: Serum creatinine (mg/dL), Blood urea nitrogen (mg/dL), Estimated glomerular filtration rate (eGFR, mL/min/1.73m²), etc.
Composite liver function profile	Baseline and 4 weeks	A composite outcome summarizing liver function biomarkers, including: Alanine aminotransferase (ALT, U/L), Aspartate aminotransferase (AST, U/L), Gamma-glutamyl transferase (GGT, U/L), Alkaline phosphatase (ALP, U/L), Total bilirubin (μmol/L), Albumin (g/L), etc.
Lipid profile	Baseline and 4 weeks	Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, etc.
Inflammatory markers	Baseline and 4 weeks	High-sensitivity C-reactive protein, etc.
Retinopathy status (digital retinal fundus imaging)	Baseline and 4 weeks	Retinopathy grading assessed by standardized digital retinal fundus images.
Composite dietary intake profile	At each meal, aggregated dayly, up to 28 days	A composite outcome summarizing dietary intake indicators, including: Total daily energy intake (kcal), Macronutrient distribution and intake (percentage and intake (gram) of total energy from carbohydrate, protein, fat, etc.), Selected micronutrient intakes (mg/day), etc.
Composite physiological monitoring profile from wearables	Daily measurements, up to 28 days	This composite outcome includes multiple physiological parameters measured via wearable devices to assess rest and recovery status. The parameters include: Sleep duration (hours), Sleep stages (percent time in REM, deep, light), Respiratory rate (breaths per minute), Heart rate (n per minute), Other relevant physiologic signals (as available from device).
Lifestyle management-related parameters	Baseline and 4 weeks	A structured lifestyle management questionnaire will be administered to assess multiple aspects of participants' personal health-related behaviours and preferences. This includes: food preference, exercise preference, past medical histories, health-related personal behaviours, etc.
Complete Blood Count	Baseline and 4 weeks
Routine urine test	Baseline and 4 weeks
Mean Glucose measured by continuous glucose monitoring	Baseline and 4 weeks
Glucose Variability measured by continuous glucose monitoring	Baseline and 4 weeks
Area Under the Curve (AUC) measured by continuous glucose monitoring	Baseline and 4 weeks
Body weight	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks	Body weight measured in kilograms using a calibrated digital scale.
Height	Baseline	Standing height measured in meters using a stadiometer.
BMI	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks	Calculated as weight in kilograms divided by height in meters squared (kg/m²).
Waist, hip and thigh circumference	Baseline, 4 weeks	Measured in centimeters
Systolic and Diastolic Blood Pressure	Baseline, 4 weeks	Systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) using an automated sphygmomanometer. Participants will be seated quietly for at least 5 minutes before measurement, and two readings will be taken 1-2 minutes apart; the average will be recorded.
Resting heart rate	Baseline, 4 weeks	Resting heart rate will be measured in beats per minute (bpm) using the automated sphygmomanometer's pulse reading or a validated heart rate monitor. Measurements will be taken in the seated position after at least 5 minutes of rest.
Genomic profiling	Baseline and 4 weeks	Whole-genome sequencing for variant analysis.
Metabolomics profiling	Baseline and 4 weeks	Untargeted metabolomics profiling using LC-MS/MS.
Proteomics profiling	Baseline and 4 weeks	Quantitative proteomics using mass spectrometry.
Fecal Metagenomics	Baseline and 4 weeks	Shotgun metagenomic sequencing of fecal samples to characterize gut microbiome taxonomic composition and functional gene profiles.
Fecal Metabolomics	Baseline and 4 weeks	Untargeted metabolomics profiling of fecal samples using liquid chromatography-mass spectrometry (LC-MS/MS) to identify and quantify metabolites.
Lipidomics profiling	Baseline and 4 weeks	Targeted lipidomics analysis of serum lipids using mass spectrometry to quantify lipid species and subclasses.
PBMC Multi-omics Profiling	Baseline and 4 weeks	Peripheral blood mononuclear cells (PBMCs) will be analyzed using multiple omics platforms to comprehensively profile molecular changes. Analyses will include: Transcriptomics: Bulk RNA sequencing to quantify gene expression. Epigenomics: Genome-wide DNA methylation profiling using bisulfite sequencing. Phosphoproteomics: Quantitative analysis of phosphorylated proteins using mass spectrometry-based phosphoproteomics to assess signaling pathway activation.; Single-cell Transcriptomics: Single-cell RNA sequencing to characterize cell type-specific transcriptional changes.; Results from these platforms will be integrated to generate a composite PBMC multi-omics dataset.
Glycemic Excursions Composite Score from Continuous Glucose Monitoring	Baseline and 4 weeks	Glycemic excursions will be evaluated using a composite measure derived from continuous glucose monitoring (CGM) data. The composite score will integrate multiple CGM-derived metrics, including: Mean glucose (mg/dL) Standard deviation of glucose (mg/dL) Coefficient of variation (%) Mean amplitude of glycemic excursions (MAGE, mg/dL)
Exercise heart rate	Each exercise session, aggregated daily up to 28 days	Average heart rate during each exercise session.
Exercise frequency	Each exercise session, aggregated daily up to 28 days	Number of completed exercise sessions.
Energy expenditure per session	Each exercise session, aggregated daily up to 28 days	Energy expenditure estimated by wearable device.
Exercise duration	Each exercise session, aggregated daily up to 28 days	Duration of each exercise session.
Number of sets and repetitions	Each exercise session, aggregated daily up to 28 days	Total sets and repetitions performed during exercise.
Exercise intensity/load	Each exercise session, aggregated daily up to 28 days	Intensity or load during exercise session (self-reported using Borg RPE scale or device-recorded).
Excess post-exercise oxygen consumption	Each exercise session, aggregated daily up to 28 days	Post-exercise oxygen consumption recorded by wearable device.
Fat mass	Baseline, 1 week, 2 week, 3 week, 4 week	Total fat mass measured by bioelectrical impedance analysis.
Fat-free mass	Baseline, 1 week, 2 week, 3 week, 4 week	Fat-free mass measured by bioelectrical impedance analysis.
Body fat percentage	Baseline, 1 week, 2 week, 3 week, 4 week	Percentage of total body weight as fat.
Visceral fat area	Baseline, 1 week, 2 week, 3 week, 4 week	Estimated visceral fat area.
Muscle mass	Baseline, 1 week, 2 week, 3 week, 4 week	Skeletal muscle mass measured by bioelectrical impedance analysis.

Trial Locations

Locations (1)

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai Municipality, China