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This is a prospective, randomized, two-armed study to assess the efficacy and safety of isocaloric dietary restriction in the treatment of obese without diabetic for a period of 4 weeks.
This is a randomized, open-label, two arms trial. Based on inclusion and exclusion criteria, 72 eligible patients, who are 18-45 years old, with BMI between 35 to 45kg/m2 are assigned to one of two intervention groups: isocaloric dietary restriction; bariatric surgery. Both groups were given a dietary intervention for a period of 4 weeks (in rigorous supervision confined in inpatient department). The main purpose of this study is to clarify the efficacy of isocaloric dietary restriction, compared to bariatric surgery, in losing weight and improving metabolic factors. This is an investigator-initiated study performed by department of endocrinology and metabolic disease, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isocaloric dietary restriction | Experimental | Very low caloric diet 400 kcal/d for a week, 600 kcal/d for another week and 800 kcal/d for 2 weeks. |
|
| Bariatric surgery | Active Comparator | Laparoscopic vertical sleeve gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isocaloric dietary restriction | Dietary Supplement | Very low caloric diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Change of body weight (kg) from baseline measured by study personnel. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index | Change of BMI [BMI = weight (kg)/height2(m2)] from baseline measured by study personnel. | 4 weeks |
| Waist, hip and neck circumference | Waist, hip and neck circumference (cm) measured by study personnel. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiqing Wang, M.D. Ph.D. | Shanghai Clinic Center for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Institute for Endocrine and Metabolic Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Bariatric surgery | Procedure | Laparoscopic vertical sleeve gastrectomy |
|
| 4 weeks |
| Body composition | Body fat mass, fat free mass (kg) and body fat rate measured by DEXA. | 4 weeks |
| Liver fat content | Liver fat content measured by MRI. | 4 weeks |
| Energy expenditure | Energy expenditure measured by metabolic chamber. | 4 weeks |
| Glucose metabolism | including glycated haemoglobin, HOMA-IR, fasting plasma glucose levels and serum insulin levels, post-prandial plasma glucose levels and serum insulin levels (using mixed-meal test). | 4 weeks |
| Lipid profiles | including serum triglycerides, total cholesterol, low-density lipoproteins cholesterol and high-density lipoproteins cholesterol. | 4 weeks |
| Gut hormones | including Glucagon-like peptide 1, gastric inhibitory polypeptide, ghrelin, peptide YY and etc. | 4 weeks |
| Hepatic function | including alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, and alkaline phosphatase. | 4 weeks |
| Renal function | including serum urea nitrogen, serum creatinine, and serum urinary acid. | 4 weeks |
| Endocrine hormones | including thyroid function, sex hormone, insulin-like growth factor and etc. | 4 weeks |
| Appetite (the subjective desire to eat) | assessed according to TFEQ-R21 | 4 weeks |
| Adverse events | Safety outcomes | 4 weeks |
| Systolic and diastolic blood pressure | Safety outcomes | 4 weeks |
| Body temperature | Safety outcomes | 4 weeks |
| Pulse rate | Safety outcomes | 4 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |