Lifestyle Intervention for Patients With Impaired Glucose Regulation

Zhejiang University

Status: Completed

Conditions: Overweight and Obesity

Treatments: Other: Low-Carbon Water Diet Intensive Intervention; Dietary Supplement: Low fat diet intensive intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04469400

2019-317

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 3 patient groups

Group1

No Intervention group

Description:

Researchers conduct health education on patients, including dietary guidance, physical activity guidance, psychological behavior counseling, etc.

Group2

Experimental group

Description:

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

Treatment:

Dietary Supplement: Low fat diet intensive intervention

Group3

Experimental group

Description:

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

Treatment:

Other: Low-Carbon Water Diet Intensive Intervention