Lifestyle Intervention for Patients With Impaired Glucose Regulation

Not Applicable

Completed

• Conditions: Overweight and Obesity

• Registration Number: NCT04469400
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive lifestyle interventions combined with blood glucose monitoring, glucose regulation of overweight/obesity is affected. To improve the blood glucose and related metabolic indexes of patients with impaired (IGR), establish 1-2 clinical intervention programs for impaired glucose regulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-07-12
• Study First Posted: 2020-07-14
• Status Verified: 2021-07
• Primary Completion: 2022-02-01
• Study Completion: 2022-12-31
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Age 18-65 years old ② Fasting blood glucose is between 5.6-6.9 mmol/L (100-125mg/dL) or oral glucose tolerance test (OGTT) 2h plasma glucose (2h-PG) is 7.8-11.1 mmol/L (140-200 mg/dL)

  • 24 kg/m2 ≤ BMI ≤ 35 kg/m2

    • Those who are willing to accept assessment and sign informed consent.

Exclusion Criteria

• Patients diagnosed with diabetes or undergoing diabetes treatment;

  • Receiving drugs or surgery for weight loss at present or in the past 3 months;

    • Receiving corticosteroid or thyroid hormone treatment;

      • Secondary obesity caused by endocrine, genetic, metabolic and central nervous system diseases;

        • Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeding the upper limit of normal value 3 times); patients with abnormal renal function (serum creatinine exceeding the upper limit of normal value); suffering from kidney disease and other diseases that need to control protein intake;

          • Diseases affecting the digestion and absorption of food (such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, gastrointestinal resection, cholecystitis/cholecystectomy, etc.); ⑦ Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases; ⑧ Suffering from infectious diseases such as active tuberculosis and AIDS; ⑨ During pregnancy or lactation; ⑩Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, have a serious disease not included in the discharge criteria) or are unwilling to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fasting blood glucose	ten weeks
Blood glucose 2 hours after meal	ten weeks

Trial Locations

Locations (8)

Cixi People's Hospital; 🇨🇳 Cixi, Zhejiang, China

Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Jinhua municipal central hospital; 🇨🇳 Jinhua, Zhejiang, China

Lishui People's Hospital; 🇨🇳 Lishui, Zhejiang, China

Ningbo Huamei Hospital, University of Chinese Academy of Sciences; 🇨🇳 Ningbo, Zhejiang, China

Shaoxing People's Hospital; 🇨🇳 Shaoxing, Zhejiang, China

The first affiliated hospital of Wenzhou medical university; 🇨🇳 Wenzhou, Zhejiang, China

Yuyao People's Hospital; 🇨🇳 Yuyao, Zhejiang, China