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OpenTrials
Active, Not Recruiting

NCT Number: NCT04024540

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isocaloric dietary restriction

Dietary Supplement

Very low caloric diet

bariatric surgery

Procedure

Laparoscopic vertical sleeve gastrectomy

Primary outcomes

  1. Body weight

    Time frame: 4 weeks

    Change of body weight (kg) from baseline measured by study personnel.

Secondary outcomes

  1. Body mass index

    Time frame: 4 weeks

    Change of BMI [BMI = weight (kg)/height2(m2)] from baseline measured by study personnel.

  2. Waist, hip and neck circumference

    Time frame: 4 weeks

    Waist, hip and neck circumference (cm) measured by study personnel.

  3. Body composition

    Time frame: 4 weeks

    Body fat mass, fat free mass (kg) and body fat rate measured by DEXA.

  4. Liver fat content

    Time frame: 4 weeks

    Liver fat content measured by MRI.

  5. Energy expenditure

    Time frame: 4 weeks

    Energy expenditure measured by metabolic chamber.

  6. Glucose metabolism

    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).

  7. Lipid profiles

    Time frame: 4 weeks

    including serum triglycerides, total cholesterol, low-density lipoproteins cholesterol and high-density lipoproteins cholesterol.

  8. Gut hormones

    Time frame: 4 weeks

    including Glucagon-like peptide 1, gastric inhibitory polypeptide, ghrelin, peptide YY and etc.

  9. Hepatic function

    Time frame: 4 weeks

    including alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, and alkaline phosphatase.

  10. Renal function

    Time frame: 4 weeks

    including serum urea nitrogen, serum creatinine, and serum urinary acid.

  11. Endocrine hormones

    Time frame: 4 weeks

    including thyroid function, sex hormone, insulin-like growth factor and etc.

  12. Appetite (the subjective desire to eat)

    Time frame: 4 weeks

    assessed according to TFEQ-R21

  13. Adverse events

    Time frame: 4 weeks

    Safety outcomes

  14. Systolic and diastolic blood pressure

    Time frame: 4 weeks

    Safety outcomes

  15. Body temperature

    Time frame: 4 weeks

    Safety outcomes

  16. Pulse rate

    Time frame: 4 weeks

    Safety outcomes

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2019
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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