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出境医 / 临床实验 / Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

Study Description
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 3 months. Then, participants would be given dietary guidance and health education and followed up for 1 year.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: isocaloric dietary restriction Procedure: Bariatric surgery Not Applicable

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. 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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment
Estimated Study Start Date : July 9, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2022
Arms and Interventions
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 and 1000 kcal/d for 2 months.
 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
Outcome Measures
Primary Outcome Measures :
  1. Body weight [ Time Frame: 1,3,6,12 month ]
    Change of body weight


Secondary Outcome Measures :
  1. Body fat mass [ Time Frame: 1,3,6,12 month ]
    Body fat mass will be measured by DEXA.

  2. Body fat free mass [ Time Frame: 1,3,6,12 month ]
    Body fat free mass will be measured by DEXA.

  3. Abdominal fat [ Time Frame: 1,3,6,12 month ]
    Abdominal fat will be measured using Magnetic Resonance Imaging.

  4. Resting energy expenditure [ Time Frame: 1,3,6,12 month ]
    Resting energy expenditure will be measured by metabolic chamber.

  5. Total energy expenditure [ Time Frame: 1,3,6,12 month ]
    Total energy expenditure will be measured by metabolic chamber.

  6. Glucose [ Time Frame: 1,3,6,12 month ]
    Glucose will be measured using an automatic biochemical analyzer.

  7. LDL-C [ Time Frame: 1,3,6,12 month ]
    LDL-C will be measured using an automatic biochemical analyzer.

  8. Blood pressure [ Time Frame: 1,3,6,12 month ]
    Both systolic pressure and diastolic pressure will be measured using electronic blood pressure monitor.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jie Hong, M.D. Ph.D. 86-021-64370045 ext 671701 hongjie@medmail.com.cn
Contact: Weiqiong Gu, M.D. Ph.D. 86-021-64370045 ext 671701

Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Layout table for investigator information
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
Tracking Information
First Submitted Date  ICMJE July 13, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date July 18, 2019
Estimated Study Start Date  ICMJE July 9, 2019
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019) 		Body weight [ Time Frame: 1,3,6,12 month ]
Change of body weight
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Body fat mass [ Time Frame: 1,3,6,12 month ]
    Body fat mass will be measured by DEXA.
  • Body fat free mass [ Time Frame: 1,3,6,12 month ]
    Body fat free mass will be measured by DEXA.
  • Abdominal fat [ Time Frame: 1,3,6,12 month ]
    Abdominal fat will be measured using Magnetic Resonance Imaging.
  • Resting energy expenditure [ Time Frame: 1,3,6,12 month ]
    Resting energy expenditure will be measured by metabolic chamber.
  • Total energy expenditure [ Time Frame: 1,3,6,12 month ]
    Total energy expenditure will be measured by metabolic chamber.
  • Glucose [ Time Frame: 1,3,6,12 month ]
    Glucose will be measured using an automatic biochemical analyzer.
  • LDL-C [ Time Frame: 1,3,6,12 month ]
    LDL-C will be measured using an automatic biochemical analyzer.
  • Blood pressure [ Time Frame: 1,3,6,12 month ]
    Both systolic pressure and diastolic pressure will be measured using electronic blood pressure monitor.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment
Official Title  ICMJE Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity 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 3 months. Then, participants would be given dietary guidance and health education and followed up for 1 year.
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. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: isocaloric dietary restriction
    Very low caloric diet
  • Procedure: Bariatric surgery
    Laparoscopic vertical sleeve gastrectomy
Study Arms  ICMJE
  • 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 and 1000 kcal/d for 2 months.
    Intervention: Dietary Supplement: isocaloric dietary restriction
  • Active Comparator: Bariatric surgery
    Laparoscopic vertical sleeve gastrectomy
    Interventions:
    • Dietary Supplement: isocaloric dietary restriction
    • Procedure: Bariatric surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019) 		72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jie Hong, M.D. Ph.D. 86-021-64370045 ext 671701 hongjie@medmail.com.cn
Contact: Weiqiong Gu, M.D. Ph.D. 86-021-64370045 ext 671701
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04024540
Other Study ID Numbers  ICMJE Ruijin-2019-34
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wang Weiqing, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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