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This study aims to improve blood glucose and weight in patients with prediabetes and obesity through health education, nutritional supplement interventions, clinical evaluation, and close clinical follow-up.100 patients with prediabetes with obesity were randomly divided into 2 groups: life intervention group, nutritional supplement intervention group. All enrolled participants were recommended for routine diabetes lifestyle education according to the "Expert Consensus on Prediabetes Intervention in Adults in China". The duration of the intervention was 3 months. The investigators aimed to compare the differences in weight, glycosylated hemoglobin, lipids and other indicators of the two groups of included populations before and after the intervention. In addition, the investigators are to explore the effects of nutritional supplement interventions on glycolipid metabolism and body weight in prediabetes with obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| life intervention group | Placebo Comparator | On the basis of the patient's original eating habits, basic dietary and lifestyle guidance is given to the patients until the end of the visit. |
|
| nutritional supplement intervention group | Experimental | On the basis of the patient's original eating habits, basic dietary and lifestyle guidance is given, and at the same time, nutritional supplements(Ivital Control) are given to instead a meal per day. 2 bags once a day until the end of the visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivital Control | Dietary Supplement | Patients in the intervention group will take 2 sachets of nutritional supplements(Ivital Control) once a day in lieu of one meal, besides receiving lifestyle interventions. |
| Measure | Description | Time Frame |
|---|---|---|
| the proportions of participants regressing back to normal glucose level | The normal glucose level was defined as FPG < 6.1 mmol/L and 2hPG < 7.8 mmol/L during the OGTT. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in HbA1c | change in HbA1c | 3 months |
| body weight | changes in body weight | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| changes in waist circumference | anthropometric parameters | 3 months |
| changes in hip circumference | anthropometric parameters | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Li, Bachelor of Medicine degree | Contact | 8613757426626 | lilyningbo@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo First Hospital | Recruiting | Ningbo | China |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069956 | Chocolate |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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|
| lifestyle intervention | Behavioral | Patients will receive lifestyle interventions. |
|
| changes in neck circumference | anthropometric parameters | 3 months |
| changes in visceral fat area | body composition | 3 months |
| changes in body fat percentage | body composition | 3 months |
| changes in lean mass | body composition | 3 months |
| blood lipids | changes in LDL-cholesterol, HDL-cholesterol | 3 months |
| changes in triglyceride level (blood lipids) | changes in triglyceride | 3 months |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |