Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: isocaloric dietary restriction; Procedure: Bariatric surgery

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: isocaloric dietary restriction; Very low caloric diet
Active Comparator: Bariatric surgery; Laparoscopic vertical sleeve gastrectomy	Dietary supplement: isocaloric dietary restriction; Very low caloric diet; Procedure: Bariatric surgery; Laparoscopic vertical sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Change of body weight (kg) from baseline measured by study personnel.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Change of BMI [BMI = weight (kg)/height2(m2)] from baseline measured by study personnel.	4 weeks
Waist, hip and neck circumference	Waist, hip and neck circumference (cm) measured by study personnel.	4 weeks
Body composition	Body fat mass, fat free mass (kg) and body fat rate measured by DEXA.	4 weeks
Liver fat content	Liver fat content measured by MRI.	4 weeks
Energy expenditure	Energy expenditure measured by metabolic chamber.	4 weeks
Glucose metabolism	including glycated haemoglobin, HOMA-IR, fasting plasma glucose levels and serum insulin levels, post-prandial plasma glucose levels and serum insulin levels (using mixed-meal test).	4 weeks
Lipid profiles	including serum triglycerides, total cholesterol, low-density lipoproteins cholesterol and high-density lipoproteins cholesterol.	4 weeks
Gut hormones	including Glucagon-like peptide 1, gastric inhibitory polypeptide, ghrelin, peptide YY and etc.	4 weeks
Hepatic function	including alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, and alkaline phosphatase.	4 weeks
Renal function	including serum urea nitrogen, serum creatinine, and serum urinary acid.	4 weeks
Endocrine hormones	including thyroid function, sex hormone, insulin-like growth factor and etc.	4 weeks
Appetite (the subjective desire to eat)	assessed according to TFEQ-R21	4 weeks
Adverse events	Safety outcomes	4 weeks
Systolic and diastolic blood pressure	Safety outcomes	4 weeks
Body temperature	Safety outcomes	4 weeks
Pulse rate	Safety outcomes	4 weeks

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Weiqing Wang, M.D. Ph.D., Shanghai Clinic Center for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Institute for Endocrine and Metabolic Diseases

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 13, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: Ruijin-2019-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No