NCT04024540

Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	isocaloric dietary restriction	Very low caloric diet
PROCEDURE	Bariatric surgery	Laparoscopic vertical sleeve gastrectomy

Timeline

• Start date: 2019-07-23
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2019-07-18
• Last updated: 2024-08-29

Locations

1 site across 1 country: China