Lifestyle Intervention for Patients With Impaired Glucose Regulation

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Low fat diet intensive intervention; Other: Low-Carbon Water Diet Intensive Intervention

• 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

Arm && Interventions

Group	Intervention	Description
Group2	Low fat diet intensive intervention	In addition to education, the subjects will consume 2 composite protein solid drinks per day, in conjunction with the three-meal diet to increase satiety and intake of sufficient nutrients
Group3	Low-Carbon Water Diet Intensive Intervention	In addition to education, the subjects will consume 2 nutrition bars daily to replace the staple food of daily lunch and dinner to help reduce carbohydrate intake and intake of sufficient nutrients

Primary Outcome Measures

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

Trial Locations

Locations (8)

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

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

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

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

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

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

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

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