Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

Shanghai Jiao Tong University School of Medicine72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

isocaloric dietary restrictionDIETARY_SUPPLEMENT

Very low caloric diet

Bariatric surgeryPROCEDURE

Laparoscopic vertical sleeve gastrectomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Ruijin hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Body weight

Change of body weight (kg) from baseline measured by study personnel.

Time frame: 4 weeks

Secondary Outcomes

Body mass index

Change of BMI \[BMI = weight (kg)/height2(m2)\] from baseline measured by study personnel.

Time frame: 4 weeks

Waist, hip and neck circumference

Waist, hip and neck circumference (cm) measured by study personnel.

Time frame: 4 weeks

Body composition

Body fat mass, fat free mass (kg) and body fat rate measured by DEXA.

Time frame: 4 weeks

Liver fat content

Liver fat content measured by MRI.

Time frame: 4 weeks

Energy expenditure

Energy expenditure measured by metabolic chamber.

Time frame: 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).

Time frame: 4 weeks

Lipid profiles

including serum triglycerides, total cholesterol, low-density lipoproteins cholesterol and high-density lipoproteins cholesterol.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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