Clinical trial NCT04469400: Lifestyle Intervention for Patients With Impaired Glucose Regulation
Official title: Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fasting blood glucose
timeFrame: ten weeks
measure: Blood glucose 2 hours after meal
timeFrame: ten weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cixi
country: China
facility: Cixi People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua municipal central hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Huamei Hospital, University of Chinese Academy of Sciences
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The first affiliated hospital of Wenzhou medical university
state: Zhejiang
city: Yuyao
country: China
facility: Yuyao People's Hospital
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Pianhong Zhang
role: PRINCIPAL_INVESTIGATOR
References: