Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-23

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

isocaloric dietary restriction

Intervention Type DIETARY_SUPPLEMENT

Very low caloric diet

Bariatric surgery

Laparoscopic vertical sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

isocaloric dietary restriction

Intervention Type DIETARY_SUPPLEMENT

Very low caloric diet

Bariatric surgery

Intervention Type PROCEDURE

Laparoscopic vertical sleeve gastrectomy

Interventions

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isocaloric dietary restriction

Very low caloric diet

Intervention Type DIETARY_SUPPLEMENT

Bariatric surgery

Laparoscopic vertical sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No