Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

Obesity Clinical Trial

Official title:

Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04024540
• Other study ID #: Ruijin-2019-34
• Status: Recruiting
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jie Hong, M.D. Ph.D.
• Phone: 86-021-64370045
• Email: hongjie[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• isocaloric dietary restriction
Very low caloric diet

Procedure:
• Bariatric surgery
Laparoscopic vertical sleeve gastrectomy

Locations

Country	Name	City	State
China	Ruijin hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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