Status:
ACTIVE_NOT_RECRUITING
Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Obesity
Eligibility:
All Genders
18-45 years
Phase:
NA
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 in...
Eligibility Criteria
Inclusion
- Age between 18 to 45 years old
- 35 ≤ BMI ≤ 45 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
July 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04024540
Start Date
July 23 2019
End Date
December 1 2024
Last Update
August 29 2024
Active Locations (1)
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1
Ruijin hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025