Ruijin hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
NCT Number: NCT04024540
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.
This study is active but is not currently recruiting participants.
18 year–45 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200025, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Very low caloric diet
Laparoscopic vertical sleeve gastrectomy
Time frame: 4 weeks
Change of body weight (kg) from baseline measured by study personnel.
Time frame: 4 weeks
Change of BMI [BMI = weight (kg)/height2(m2)] from baseline measured by study personnel.
Time frame: 4 weeks
Waist, hip and neck circumference (cm) measured by study personnel.
Time frame: 4 weeks
Body fat mass, fat free mass (kg) and body fat rate measured by DEXA.
Time frame: 4 weeks
Liver fat content measured by MRI.
Time frame: 4 weeks
Energy expenditure measured by metabolic chamber.
Time frame: 4 weeks
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).
Time frame: 4 weeks
including serum triglycerides, total cholesterol, low-density lipoproteins cholesterol and high-density lipoproteins cholesterol.
Time frame: 4 weeks
including Glucagon-like peptide 1, gastric inhibitory polypeptide, ghrelin, peptide YY and etc.
Time frame: 4 weeks
including alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, and alkaline phosphatase.
Time frame: 4 weeks
including serum urea nitrogen, serum creatinine, and serum urinary acid.
Time frame: 4 weeks
including thyroid function, sex hormone, insulin-like growth factor and etc.
Time frame: 4 weeks
assessed according to TFEQ-R21
Time frame: 4 weeks
Safety outcomes
Time frame: 4 weeks
Safety outcomes
Time frame: 4 weeks
Safety outcomes
Time frame: 4 weeks
Safety outcomes
Shanghai Jiao Tong University School of Medicine
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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