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Lifestyle intervention in patients with type 2 diabetes mellitus: a national multicenter randomized controlled trial

Lifestyle intervention in patients with type 2 diabetes mellitus: a national multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102987
Enrollment
Unknown
Registered
2025-05-22
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

Routine health education group:regular online and offline health education
A priori lifestyle intervention group:The patients were guided by professional dietitian and sports medicine doctor according to the diet and exercise lifestyle recommended by the Chinese Guidelines f
Data-driven precision intervention group:The GUIDE-T2DM model provides personalized and precise lifestyle guidance by professional nutritionists and sports medicine physicians.

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Type 2 diabetic patients with disease duration10 <= years; (2) Aged 18-75 years old; (3) HbA1c < 10%; (4) BMI < 40kg/m^2; (5) Stable medication for 1 month before enrollment; (6) Voluntarily participated in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; (2) Have participated in any clinical trial of an approved or unapproved investigational drug within 30 days before screening; (3) Renal insufficiency (eGFR < 60); (4) Hepatic dysfunction (Child-Pugh class C); (5) Uncontrolled hypertension with myocardial infarction, transient ischemic attack, acute coronary syndrome, clinically diagnosed chronic heart failure (New York Heart Association class II-IV), or hospitalization for heart failure within 60 days before screening; (6) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy; (7) Presence or history of malignancy within 5 years before screening; (8) Prior solid organ transplantation or waiting for solid organ transplantation; (9) The PAR-Q questionnaire was not suitable for exercise as assessed by a professional physician.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
24 hrs TIR;fasting blood glucose;2-hour postprandial hyperglycemia;Changes in the dosage of hypoglycemic drugs;Diabetic Nephropathy;diabetic retinopathy;diabetic neuropathy;The first occurrence of a composite cardiovascular event (including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization due to angina pectoris);Body Mass Index;Body Weight;waistline;percentage of body fat;blood lipid profile;hepatic function;fatty liver;Metabolomics indicators;Blood Pressure;The usage of antihypertensive drugs;

Countries

China

Contacts

Public ContactLiu Xiaoxia

Huashan Hospital Affiliated to Fudan University

xiaoxialiu@fudan.edu.cn+86 139 1605 0179

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026