Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

Not Applicable

Active, not recruiting

• Conditions: Obesity
• Interventions: Dietary Supplement: isocaloric dietary restriction; Procedure: Bariatric surgery

• Registration Number: NCT04024540
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study First Submitted: 2019-07-13
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-18
• Study Start: 2019-07-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bariatric surgery	isocaloric dietary restriction	Laparoscopic vertical sleeve gastrectomy
isocaloric dietary restriction	isocaloric dietary restriction	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	Bariatric surgery	Laparoscopic vertical sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
Body weight	4 weeks	Change of body weight (kg) from baseline measured by study personnel.

Secondary Outcome Measures

Name	Time	Method
Energy expenditure	4 weeks	Energy expenditure measured by metabolic chamber.
Lipid profiles	4 weeks	including serum triglycerides, total cholesterol, low-density lipoproteins cholesterol and high-density lipoproteins cholesterol.
Renal function	4 weeks	including serum urea nitrogen, serum creatinine, and serum urinary acid.
Liver fat content	4 weeks	Liver fat content measured by MRI.
Waist, hip and neck circumference	4 weeks	Waist, hip and neck circumference (cm) measured by study personnel.
Body mass index	4 weeks	Change of BMI \[BMI = weight (kg)/height2(m2)\] from baseline measured by study personnel.
Body composition	4 weeks	Body fat mass, fat free mass (kg) and body fat rate measured by DEXA.
Gut hormones	4 weeks	including Glucagon-like peptide 1, gastric inhibitory polypeptide, ghrelin, peptide YY and etc.
Systolic and diastolic blood pressure	4 weeks	Safety outcomes
Body temperature	4 weeks	Safety outcomes
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).
Hepatic function	4 weeks	including alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, and alkaline phosphatase.
Appetite (the subjective desire to eat)	4 weeks	assessed according to TFEQ-R21
Pulse rate	4 weeks	Safety outcomes
Endocrine hormones	4 weeks	including thyroid function, sex hormone, insulin-like growth factor and etc.
Adverse events	4 weeks	Safety outcomes

Trial Locations

Locations (1)

Ruijin hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China