Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

Shanghai Jiao Tong University School of Medicine

Status: Active, not recruiting

Conditions: Obesity

Treatments: Dietary Supplement: isocaloric dietary restriction; Procedure: Bariatric surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04024540

Ruijin-2019-34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

isocaloric dietary restriction

Experimental group

Description:

Very low caloric diet 400 kcal/d for a week, 600 kcal/d for another week and 800 kcal/d for 2 weeks.

Treatment:

Dietary Supplement: isocaloric dietary restriction

Bariatric surgery

Active Comparator group

Description:

Laparoscopic vertical sleeve gastrectomy

Treatment:

Procedure: Bariatric surgery

Dietary Supplement: isocaloric dietary restriction