Status:

COMPLETED

Lifestyle Intervention for Patients With Impaired Glucose Regulation

Lead Sponsor:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Conditions:

Overweight and Obesity

Eligibility:

All Genders

18-65 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2022

Estimated Enrollment :

116 Patients enrolled

Trial Details

Trial ID

NCT04469400

Start Date

May 1 2020

End Date

December 31 2022

Last Update

June 24 2024

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Cixi People's Hospital

Cixi, Zhejiang, China, 315300

2

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

3

Jinhua municipal central hospital

Jinhua, Zhejiang, China, 321000

4

Lishui People's Hospital

Lishui, Zhejiang, China, 323020