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Lifestyle Interventions for Pre-Diabetic Populations of Type 2 Diabetes: A National Multicenter Randomized Controlled Trial (RCT) Study

Lifestyle Interventions for Pre-Diabetic Populations of Type 2 Diabetes: A National Multicenter Randomized Controlled Trial (RCT) Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106411
Enrollment
Unknown
Registered
2025-07-23
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

type 2 diabetes

Interventions

control group:Maintain the old way of life.
a priori lifestyle intervention group:Lifestyle intervention regimen as prescribed by the guidelines.
data-driven precision intervention group:Evidence-based and data-driven improved and optimized dietary exercise intervention programs.

Sponsors

Harbin Medical University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) prediabetes in the age range of 30 to 65 years; (2) diagnosis of prediabetes according to the criteria of WHO 1999 or ADA 2022, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and a mixed state of both (IFG+IGT); (3) glycosylated hemoglobin (HbA1c) between 5.7%-6.4%; (4) no serious complications such as cardiovascular and cerebrovascular diseases, kidney diseases, liver diseases, malignant tumors, etc.; (5) BMI between 24.0 and 35.0 kg/m^2; (6) local resident population; (7) willingness to make lifestyle changes, including diet and exercise habits; (8) voluntarily participate in the study and sign the informed consent form;

Exclusion criteria

Exclusion criteria: (1) Patients who have been diagnosed with diabetes mellitus (including type 1 and type 2); (2) Severe endocrine diseases, such as thyroid dysfunction, adrenal gland diseases, etc., endocrine diseases that may affect glucose metabolism; (3) Have serious cardiovascular diseases, such as unstable angina, recent myocardial infarction, severe heart failure, etc.; (4) Exclusion of people with kidney disease and liver disease: (5) Exclusion of disability, cancer or infectious diseases such as tuberculosis and AIDS: (6) Participation in other intervention studies, hypersensitivity to study drugs or methods, other conditions deemed inappropriate by the investigator for participation.

Design outcomes

Primary

MeasureTime frame
blood sugar;blood lipids;blood pressure;gut microbiota;

Secondary

MeasureTime frame
weight;Fasting blood glucose;2 hour postprandial blood glucose;Glycosylated hemoglobin;waist circumference;C-reactive protein;Tumor necrosis factor-a;Interleukin-6;Superoxide dismutase;Catalase;

Countries

China

Contacts

Public ContactYucun Niu

School of Public Health, Harbin Medical University.

niuyucun@163.com+86 188 4618 1358

Outcome results

None listed

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