Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTisocaloric dietary restriction
Very low caloric diet
PROCEDUREBariatric surgery
Laparoscopic vertical sleeve gastrectomy
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 to 45 years old * 35 ≤ BMI ≤ 45 kg/m2
Exclusion criteria
* Obesity induced by other endocrinologic disorders * Severe gastrointestinal diseases or contraindication for surgery * History or newly known of diabetes * Use of hypoglycemic medications, antibiotic in the preceding 2 months, or yogurt within 5 days * Weight change more than 5% of body weight within the past 3 months * Severe or unstable cardiovascular, liver or renal diseases or known cancer * History of drug or alcohol abuse or other substance abuse * Any mental disorders or current use of antidepressantsPregnancy or lactation or consideration of pregnancy * Allergies to specific food ingredients in the intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 4 weeks | Change of body weight (kg) from baseline measured by study personnel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist, hip and neck circumference | 4 weeks | Waist, hip and neck circumference (cm) measured by study personnel. |
| Body composition | 4 weeks | Body fat mass, fat free mass (kg) and body fat rate measured by DEXA. |
| Liver fat content | 4 weeks | Liver fat content measured by MRI. |
| Energy expenditure | 4 weeks | Energy expenditure measured by metabolic chamber. |
| Glucose metabolism | 4 weeks | 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). |
| Lipid profiles | 4 weeks | including serum triglycerides, total cholesterol, low-density lipoproteins cholesterol and high-density lipoproteins cholesterol. |
| Gut hormones | 4 weeks | including Glucagon-like peptide 1, gastric inhibitory polypeptide, ghrelin, peptide YY and etc. |
| Body mass index | 4 weeks | Change of BMI \[BMI = weight (kg)/height2(m2)\] from baseline measured by study personnel. |
| Renal function | 4 weeks | including serum urea nitrogen, serum creatinine, and serum urinary acid. |
| Endocrine hormones | 4 weeks | including thyroid function, sex hormone, insulin-like growth factor and etc. |
| Appetite (the subjective desire to eat) | 4 weeks | assessed according to TFEQ-R21 |
| Adverse events | 4 weeks | Safety outcomes |
| Systolic and diastolic blood pressure | 4 weeks | Safety outcomes |
| Body temperature | 4 weeks | Safety outcomes |
| Pulse rate | 4 weeks | Safety outcomes |
| Hepatic function | 4 weeks | including alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, and alkaline phosphatase. |
Countries
China
Outcome results
None listed