Lifestyle Intervention for Patients With Impaired Glucose Regulation

Study Overview
=================
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.

Official Title
-----------------
Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation

Conditions
-----------------
Overweight and Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Low fat diet intensive intervention
* Other: Low-Carbon Water Diet Intensive Intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group1<br>Researchers conduct health education on patients, including dietary guidance, physical activity guidance, psychological behavior counseling, etc. | |
| Experimental: Group2<br>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 | Dietary Supplement: Low fat diet intensive intervention<br>* education and Compound protein solid beverage<br>|
| Experimental: Group3<br>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 | Other: Low-Carbon Water Diet Intensive Intervention<br>* education and Nutrition bar<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose |  | ten weeks | 
| Blood glucose 2 hours after meal |  | ten weeks |