Clinical trial NCT04024540: Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment
Official title: Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: 4 weeks
Secondary outcomes:
measure: Body mass index
timeFrame: 4 weeks
measure: Waist, hip and neck circumference
timeFrame: 4 weeks
measure: Body composition
timeFrame: 4 weeks
measure: Liver fat content
timeFrame: 4 weeks
measure: Energy expenditure
timeFrame: 4 weeks
measure: Glucose metabolism
timeFrame: 4 weeks
measure: Lipid profiles
timeFrame: 4 weeks
measure: Gut hormones
timeFrame: 4 weeks
measure: Hepatic function
timeFrame: 4 weeks
measure: Renal function
timeFrame: 4 weeks
measure: Endocrine hormones
timeFrame: 4 weeks
measure: Appetite (the subjective desire to eat)
timeFrame: 4 weeks
measure: Adverse events
timeFrame: 4 weeks
measure: Systolic and diastolic blood pressure
timeFrame: 4 weeks
measure: Body temperature
timeFrame: 4 weeks
measure: Pulse rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Clinic Center for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Institute for Endocrine and Metabolic Diseases
name: Weiqing Wang, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: