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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle intervention Arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Management | Other | Participants will undergo dietary and exercise interventions. The dietary intervention includes breakfast, lunch, and dinner, while the exercise intervention consists of both aerobic and resistance training. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-intervention incremental area under the glucose curve (iAUC) measured by continuous glucose monitoring (CGM) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Baseline and 4 weeks |
| Composite kidney function profile | 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. | Baseline and 4 weeks |
| Composite liver function profile | 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. | Baseline and 4 weeks |
| Lipid profile | Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, etc. | Baseline and 4 weeks |
| Inflammatory markers | High-sensitivity C-reactive protein, etc. | Baseline and 4 weeks |
| Retinopathy status (digital retinal fundus imaging) | Retinopathy grading assessed by standardized digital retinal fundus images. | Baseline and 4 weeks |
| Composite dietary intake profile | 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. | At each meal, aggregated dayly, up to 28 days |
| Composite physiological monitoring profile from wearables | 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). | Daily measurements, up to 28 days |
| Lifestyle management-related parameters | 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. | Baseline and 4 weeks |
| 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 | Body weight measured in kilograms using a calibrated digital scale. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Height | Standing height measured in meters using a stadiometer. | Baseline |
| BMI | Calculated as weight in kilograms divided by height in meters squared (kg/m²). | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Waist, hip and thigh circumference | Measured in centimeters | Baseline, 4 weeks |
| Systolic and Diastolic Blood Pressure | 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. | Baseline, 4 weeks |
| Resting heart rate | 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. | Baseline, 4 weeks |
| Genomic profiling | Whole-genome sequencing for variant analysis. | Baseline and 4 weeks |
| Metabolomics profiling | Untargeted metabolomics profiling using LC-MS/MS. | Baseline and 4 weeks |
| Proteomics profiling | Quantitative proteomics using mass spectrometry. | Baseline and 4 weeks |
| Fecal Metagenomics | Shotgun metagenomic sequencing of fecal samples to characterize gut microbiome taxonomic composition and functional gene profiles. | Baseline and 4 weeks |
| Fecal Metabolomics | Untargeted metabolomics profiling of fecal samples using liquid chromatography-mass spectrometry (LC-MS/MS) to identify and quantify metabolites. | Baseline and 4 weeks |
| Lipidomics profiling | Targeted lipidomics analysis of serum lipids using mass spectrometry to quantify lipid species and subclasses. | Baseline and 4 weeks |
| PBMC Multi-omics Profiling | 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. | Baseline and 4 weeks |
| Glycemic Excursions Composite Score from Continuous Glucose Monitoring | 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) | Baseline and 4 weeks |
| Exercise heart rate | Average heart rate during each exercise session. | Each exercise session, aggregated daily up to 28 days |
| Exercise frequency | Number of completed exercise sessions. | Each exercise session, aggregated daily up to 28 days |
| Energy expenditure per session | Energy expenditure estimated by wearable device. | Each exercise session, aggregated daily up to 28 days |
| Exercise duration | Duration of each exercise session. | Each exercise session, aggregated daily up to 28 days |
| Number of sets and repetitions | Total sets and repetitions performed during exercise. | Each exercise session, aggregated daily up to 28 days |
| Exercise intensity/load | Intensity or load during exercise session (self-reported using Borg RPE scale or device-recorded). | Each exercise session, aggregated daily up to 28 days |
| Excess post-exercise oxygen consumption | Post-exercise oxygen consumption recorded by wearable device. | Each exercise session, aggregated daily up to 28 days |
| Fat mass | Total fat mass measured by bioelectrical impedance analysis. | Baseline, 1 week, 2 week, 3 week, 4 week |
| Fat-free mass | Fat-free mass measured by bioelectrical impedance analysis. | Baseline, 1 week, 2 week, 3 week, 4 week |
| Body fat percentage | Percentage of total body weight as fat. | Baseline, 1 week, 2 week, 3 week, 4 week |
| Visceral fat area | Estimated visceral fat area. | Baseline, 1 week, 2 week, 3 week, 4 week |
| Muscle mass | Skeletal muscle mass measured by bioelectrical impedance analysis. | Baseline, 1 week, 2 week, 3 week, 4 week |