DiabetesNCT07146308
Multi-omics Mechanisms of Lifestyle Intervention in Regulating Blood Glucose
A study testing Lifestyle Management in people with Diabetes, run by Shanghai 6th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Lifestyle Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-70 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official title: Multiscale Causal Disease Warning and Assisted Diagnosis: Multi-omics Mechanisms of Lifestyle Intervention in Regulating Blood Glucose
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.
- Conditions
- Diabetes
- Being tested
- Lifestyle Management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention Arm | Experimental | Not described Receives: Other: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention incremental area under the glucose curve (iAUC) measured by continuous glucose monitoring (CGM)
Measured: 4 weeks
Secondary outcomes (41)
Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR) Measured by Continuous Glucose Monitoring
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks
Lipid profile
Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, etc.
Measured: Baseline and 4 weeks
Inflammatory markers
High-sensitivity C-reactive protein, etc.
Measured: Baseline and 4 weeks
Retinopathy status (digital retinal fundus imaging)
Retinopathy grading assessed by standardized digital retinal fundus images.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and 4 weeks
Complete Blood Count
Measured: Baseline and 4 weeks
Routine urine test
Measured: Baseline and 4 weeks
Mean Glucose measured by continuous glucose monitoring
Measured: Baseline and 4 weeks
Glucose Variability measured by continuous glucose monitoring
Measured: Baseline and 4 weeks
Area Under the Curve (AUC) measured by continuous glucose monitoring
Measured: Baseline and 4 weeks
Body weight
Body weight measured in kilograms using a calibrated digital scale.
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Height
Standing height measured in meters using a stadiometer.
Measured: Baseline
BMI
Calculated as weight in kilograms divided by height in meters squared (kg/m²).
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Waist, hip and thigh circumference
Measured in centimeters
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks
Genomic profiling
Whole-genome sequencing for variant analysis.
Measured: Baseline and 4 weeks
Metabolomics profiling
Untargeted metabolomics profiling using LC-MS/MS.
Measured: Baseline and 4 weeks
Proteomics profiling
Quantitative proteomics using mass spectrometry.
Measured: Baseline and 4 weeks
Fecal Metagenomics
Shotgun metagenomic sequencing of fecal samples to characterize gut microbiome taxonomic composition and functional gene profiles.
Measured: 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.
Measured: Baseline and 4 weeks
Lipidomics profiling
Targeted lipidomics analysis of serum lipids using mass spectrometry to quantify lipid species and subclasses.
Measured: 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.
Measured: 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)
Measured: Baseline and 4 weeks
Exercise heart rate
Average heart rate during each exercise session.
Measured: Each exercise session, aggregated daily up to 28 days
Exercise frequency
Number of completed exercise sessions.
Measured: Each exercise session, aggregated daily up to 28 days
Energy expenditure per session
Energy expenditure estimated by wearable device.
Measured: Each exercise session, aggregated daily up to 28 days
Exercise duration
Duration of each exercise session.
Measured: Each exercise session, aggregated daily up to 28 days
Number of sets and repetitions
Total sets and repetitions performed during exercise.
Measured: 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).
Measured: Each exercise session, aggregated daily up to 28 days
Excess post-exercise oxygen consumption
Post-exercise oxygen consumption recorded by wearable device.
Measured: Each exercise session, aggregated daily up to 28 days
Fat mass
Total fat mass measured by bioelectrical impedance analysis.
Measured: Baseline, 1 week, 2 week, 3 week, 4 week
Fat-free mass
Fat-free mass measured by bioelectrical impedance analysis.
Measured: Baseline, 1 week, 2 week, 3 week, 4 week
Body fat percentage
Percentage of total body weight as fat.
Measured: Baseline, 1 week, 2 week, 3 week, 4 week
Visceral fat area
Estimated visceral fat area.
Measured: Baseline, 1 week, 2 week, 3 week, 4 week
Muscle mass
Skeletal muscle mass measured by bioelectrical impedance analysis.
Measured: Baseline, 1 week, 2 week, 3 week, 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start31 Aug 2025
- Primary completion30 Sep 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Huating, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146308
- Sponsor's protocol ID
- 2025-KY-239(K)
- Status last verified
- Nov 2025
- First submitted
- 13 Jul 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiscale Causal Disease Warning and Assisted Diagnosis: Multi-omics Mechanisms of Lifestyle Intervention in Regulating Blood Glucose
- ClinicalTrials.gov ID
- NCT07146308
- Acronym / sponsor ID
- 2025-KY-239(K)
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention Arm | Experimental | Other: Lifestyle Management |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18-70 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ManagementParticipants 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. | Other | Lifestyle intervention Arm |
Primary outcome
Post-intervention incremental area under the glucose curve (iAUC) measured by continuous glucose monitoring (CGM)
Time frame: 4 weeks
41 secondary outcomes
Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR) Measured by Continuous Glucose Monitoring
Time frame: Baseline and 4 weeks
Composite glucose metabolism profile
Time frame: Baseline and 4 weeks
Composite kidney function profile
Time frame: Baseline and 4 weeks
Composite liver function profile
Time frame: Baseline and 4 weeks
Lipid profile
Time frame: Baseline and 4 weeks
Inflammatory markers
Time frame: Baseline and 4 weeks
Retinopathy status (digital retinal fundus imaging)
Time frame: Baseline and 4 weeks
Composite dietary intake profile
Time frame: At each meal, aggregated dayly, up to 28 days
Composite physiological monitoring profile from wearables
Time frame: Daily measurements, up to 28 days
Lifestyle management-related parameters
Time frame: Baseline and 4 weeks
Complete Blood Count
Time frame: Baseline and 4 weeks
Routine urine test
Time frame: Baseline and 4 weeks
Mean Glucose measured by continuous glucose monitoring
Time frame: Baseline and 4 weeks
Glucose Variability measured by continuous glucose monitoring
Time frame: Baseline and 4 weeks
Area Under the Curve (AUC) measured by continuous glucose monitoring
Time frame: Baseline and 4 weeks
Body weight
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Height
Time frame: Baseline
BMI
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Waist, hip and thigh circumference
Time frame: Baseline, 4 weeks
Systolic and Diastolic Blood Pressure
Time frame: Baseline, 4 weeks
Resting heart rate
Time frame: Baseline, 4 weeks
Genomic profiling
Time frame: Baseline and 4 weeks
Metabolomics profiling
Time frame: Baseline and 4 weeks
Proteomics profiling
Time frame: Baseline and 4 weeks
Fecal Metagenomics
Time frame: Baseline and 4 weeks
Fecal Metabolomics
Time frame: Baseline and 4 weeks
Lipidomics profiling
Time frame: Baseline and 4 weeks
PBMC Multi-omics Profiling
Time frame: Baseline and 4 weeks
Glycemic Excursions Composite Score from Continuous Glucose Monitoring
Time frame: Baseline and 4 weeks
Exercise heart rate
Time frame: Each exercise session, aggregated daily up to 28 days
Exercise frequency
Time frame: Each exercise session, aggregated daily up to 28 days
Energy expenditure per session
Time frame: Each exercise session, aggregated daily up to 28 days
Exercise duration
Time frame: Each exercise session, aggregated daily up to 28 days
Number of sets and repetitions
Time frame: Each exercise session, aggregated daily up to 28 days
Exercise intensity/load
Time frame: Each exercise session, aggregated daily up to 28 days
Excess post-exercise oxygen consumption
Time frame: Each exercise session, aggregated daily up to 28 days
Fat mass
Time frame: Baseline, 1 week, 2 week, 3 week, 4 week
Fat-free mass
Time frame: Baseline, 1 week, 2 week, 3 week, 4 week
Body fat percentage
Time frame: Baseline, 1 week, 2 week, 3 week, 4 week
Visceral fat area
Time frame: Baseline, 1 week, 2 week, 3 week, 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Management in people with Diabetes, run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-intervention incremental area under the glucose curve (iAUC) measured by continuous glucose monitoring (CGM) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.