Lifestyle Intervention for Patients With Impaired Glucose Regulation

Overweight and Obesity Clinical Trial

Official title:

Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04469400
• Other study ID #: 2019-317
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Pianhong zhang
• Phone: 057187783851
• Email: zrlcyyzx[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years old ? 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.); ? Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases; ? Suffering from infectious diseases such as active tuberculosis and AIDS; ? During pregnancy or lactation; ?Patients 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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Low fat diet intensive intervention
education and Compound protein solid beverage

Other:
• Low-Carbon Water Diet Intensive Intervention
education and Nutrition bar

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose		ten weeks
Primary	Blood glucose 2 hours after meal		ten weeks