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Lifestyle intervention in a national multicenter randomized controlled study in people at high risk of type 2 diabetes

Lifestyle intervention in a national multicenter randomized controlled study in people at high risk of type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106887
Enrollment
Unknown
Registered
2025-07-31
Start date
2025-08-01
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

High-risk population for type 2 diabetes

Interventions

Routine education group:Distribute the type 2 diabetes prevention and treatment education manual to the routine education group. They will not participate in exercise and nutrition interventions and a
Exercise intervention group:A multimodal exercise program combining moderate-intensity aerobic exercise, resistance training, and Baduanjin (a traditional Chinese exercise): Aerobic exercise: Step aer
Dietary intervention group:Low-Carb Diet (LCD): 30%–40% carbohydrates, with an increase in healthy fats (such as avocado and nuts). This plan includes specific meal distribution examples and a food su
Lifestyle intervention group.:Lifestyle intervention measures include adjustments in both diet and exercise to improve individual health. In terms of dietary intervention, we provide each participant

Sponsors

Shandong Sport University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients must meet one of the following inclusion criteria in Articles 1, 2 and 3-12: 1. Participants voluntarily join this study, sign the informed consent form, and strictly abide by the requirements of the study protocol; 2. Adults aged >=18-70 years old; 3. History of prediabetes; However, at present, OGTT shows normal blood glucose; 4. Overweight (BMI>=24) or obese (BMI>=28) and/or abdominal obesity (waist circumference >=90 cm for men and >=85 cm for women); 5. Sedentary lifestyle (Note: Definition of sedentary lifestyle: usually within 1 day, the cumulative time of static behaviors such as working, studying, reading, watching TV, using computers, and resting (excluding sleeping time) is >6 hours); 6. Type 2 diabetes mellitus in first-degree relatives; 7. Hypertension (systolic blood pressure >=140 mmHg) and/or diastolic blood pressure >= 90 mmHg or receiving antihypertensive therapy; 8. Dyslipidemia [HDL cholesterol=2.22 mmol/L] or receiving lipid-regulating therapy; 9. Patients with coronary atherosclerotic cardiovascular disease; 10. Those who have a history of transient steroidal diabetes; 11. Patients with polycystic ovary syndrome or with clinical conditions related to insulin resistance; 12. The total score of the Chinese diabetes risk score >=25 points.

Exclusion criteria

Exclusion criteria: 1. Patients who have been diagnosed with type 1 or type 2 diabetes; 2. Cardiovascular disease, renal insufficiency, hepatic insufficiency, cancer, or other serious diseases that affect the study intervention; 3. Pregnant or lactating women; 4. Current use of drugs that may affect blood glucose levels and drugs that may increase appetite (oral contraceptives, acetylsalicylic acid, steroids, protease inhibitors, including antipsychotics, such as chlorpromazine, fenazine, clozapine, eperidone, olanzapine, paliperidone, quetiapine, risperidone, etc., or have plans to take related drugs during the study); 5. Diseases affecting energy, glucose metabolism or requiring specific and intensive dietary management (oncology, HIV, adrenal-related diseases, insulinoma, chronic kidney disease, acromegaly, hyperthyroidism or hypothyroidism, cirrhosis, inflammatory bowel disease, cardiomyopathy, arrhythmias, chronic obstructive pulmonary disease); 6. Have serious mental or psychological illness; Including patients who have been emotionally stable after drug treatment and have a history of serious mental or psychological illness who have stopped taking medication for less than 3 months; 7. Those who have allergic reactions or specific dietary needs (such as vegetarian, vegan, ketogenic diet, Ramadan for special beliefs, etc.) or are receiving counseling from a dietitian; 8. Night shift workers, shift workers, insomnia = 4 nights/week; 9. Smokers, alcoholics, or drug abuse; 10. Have had a heart attack (myocardial infarction) or stroke in the past 6 months; 11. Those who have a significant record of poor compliance or cannot guarantee compliance with the study protocol.

Design outcomes

Primary

MeasureTime frame
Blood glucose control-related indicators.;Insulin-related indicators.;Lipid profile-related indicators.;Exercise function-related indicators;Body composition-related indicators;Exercise metabolism-related indicators;Exercise adherence-related indicators;

Secondary

MeasureTime frame
Nutrition-related indicators;Quality of life-related indicators.;

Countries

China

Contacts

Public ContactTian Xuewen

Shandong Sport University

Xuewentian1978@163.com+86 138 5418 9377

Outcome results

None listed

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