Multi-omics Mechanisms of Lifestyle Intervention in Regulating Blood Glucose

NCT07146308 | Completed DMC

• 1 other identifier: 2025-KY-239(K)
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Post-intervention incremental area under the glucose curve (iAUC) measured by continuous glucose monitoring (CGM)

  4 weeks

Secondary Outcomes (41)

• 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

• Composite kidney function profile

  Baseline and 4 weeks

• Composite liver function profile

  Baseline and 4 weeks

• Lipid profile

  Baseline and 4 weeks

Study Arms (1)

Lifestyle intervention Arm

EXPERIMENTAL

Other: Lifestyle Management

Interventions

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.

Lifestyle intervention Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: August 28, 2025
• Study Start: August 31, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

CN (1)