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Intensive Lifestyle Intervention for Remission of Metabolic Syndrome (LIMS)

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ClinicalTrials.gov Identifier: NCT04116905
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : May 14, 2020
Sponsor:
Collaborators:
Zhejiang Provincial People's Hospital
Zhejiang Xiaoshan hospital
The 907th PLA joint logistic support force hospital
Xiangya Hospital of Central South University
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
First affiliated hospital of Nanhua University
General hospital of the PLA central theater
Shanghai First People's hospital, Fudan University
First affiliated hospital of Nanchang University
Second Affiliated Hospital of Nanchang University
First Affiliated Hospital of Guangxi Medical University
First Affiliated Hospital, Henan University of Science and Technology
Second people's hospital of Guangdong province
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Tracking Information
First Submitted Date  ICMJE September 16, 2019
First Posted Date  ICMJE October 7, 2019
Last Update Posted Date May 14, 2020
Actual Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
  • The remission rate of metabolic syndrome [ Time Frame: 12 months ]
    Participants who no longer meet the diagnostic criteria of metabolic syndrome. meet 2 or less of the following 5 criteria: Waist circumference ≥85 cm (male) or 80 cm (female); TG ≥150 mg/dL or with lipid-lowering treatment; HDL<40 mg/dL (male) /50 mg/dL (female);SBP ≥ 130 mmHg and / or DBP ≥ 85 mmHg and / or with diagnosed hypertension and anti-hypertensive treatment; fasting glucose ≥ 5.6 mmol/L and / or with diagnosed type 2 diabetes and anti-hyperglycemic treatment.
  • The proportion of participants with wight loss exceeding 15% [ Time Frame: 12 months ]
    The proportion of participants maintaining a weight loss of more than 15%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
  • Remission of hypertension [ Time Frame: 12 months ]
    The proportion with BP<130/85mmHg or BP<140/90mmHg without medication.
  • Remission of hyperglycemia [ Time Frame: 12 months ]
    The proportion with fasting blood glucose <5.6 mmol/L without medication.
  • Remission of hypertriglyceridemia [ Time Frame: 12 months ]
    The proportion with blood triglyceride<150 mg/dl without medication.
  • Remission of low HDL-C [ Time Frame: 12 months ]
    The proportion with HDL-C≥40 mg/dl in male or ≥50 mg/dl in female without medication.
  • Remission of central obesity [ Time Frame: 12 months ]
    The proportion with waist circumference <85 cm in male or <80 cm in female.
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 Intensive Lifestyle Intervention for Remission of Metabolic Syndrome
Official Title  ICMJE Intensive Lifestyle Intervention for Remission of Metabolic Syndrome in Overweight or Obese Han Chinese Population
Brief Summary It is a multi-center, randomized, prospective clinical study in metabolic syndrome with obese and overweight of Han Chinese population. The purpose of the study is to examine the effect of a programed intensive lifestyle intervention on weight loss (15%) and the remission of metabolic syndrome, and also its underlying mechanisms.
Detailed Description

Metabolic syndrome is a worldwide problem to public health, with a prevalence rate of 10-84% according to previous studies. It is associated with a series of chronic non-communicable diseases, including type 2 diabetes, cardiovascular diseases, non-alcoholic fatty liver, polycystic ovary syndrome, cancer, and etc. Worth noting, obesity contributed a lot to the occurrence of metabolic syndrome, and many studies had proven the positive significance of sufficient weight loss to the improvement of components of metabolic syndrome.

The study is examining the effect of an intensive lifestyle intervention program, designed to achieve and maintain a 15% decrease in body weight by intensive calorie restriction and physical exercise, in overweight and obese volunteers with metabolic syndrome. In this program, volunteers will be supposed on very low calorie diet with partial diet replacement, followed by carefully managed food reintroduction and then weight loss maintenance. In addtion, mobile phone applications (apps) will be used during the weight loss program.

The control group will be involved in a control condition involving a program of metabolic support and education, designed to achieve and maintain a 5% decrease in body weight. Mobile phone applications (apps) will be alos adopted during the weight loss program.

The study will also test the effect of intensive lifestyle intervention on appetite, body fat, abdominal fat, gut microbiota, bone mineral density, vascular endothelial function, and etc.

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 Metabolic Syndrome
Intervention  ICMJE
  • Behavioral: Intensive Lifestyle Intervention
    The lifestyle intervention is implemented with individual supervision sessions and is aimed at achieving and maintaining at least a 15% decrease in weight from baseline. It is implemented during a 12-month period with the most intensive application during the first 4 months. To help participants achieve and maintain weight loss, partial diet replacement with very low calorie diet, strengthend exercise strategies. Mobile phone applications (apps) will be used to manage metabolic syndrome during weight loss program. Optional medications on metabolic syndrome will be utilized based on a preset algorithm and participant progress.
  • Behavioral: Conventional Treatment
    Participants assigned to conventional treatment and education are offered metabolic syndrome management and social support every 1 month, aimed at achieving and maintaining a 5% decrease in weight in 1 year. Mobile phone applications (apps) will also be used in the weight loss program.
Study Arms  ICMJE
  • Experimental: Intensive Lifestyle Intervention
    Participants in the intensive lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain a 15% weight loss.
    Intervention: Behavioral: Intensive Lifestyle Intervention
  • Active Comparator: Conventional Treatment
    The conventional treatment arm provides group sessions on metabolic syndrome management and social support, aimed at a 5% weight loss.
    Intervention: Behavioral: Conventional Treatment
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI of 27-45 kg/m2
  • Metabolic syndrome: meet at least 3 of the following 5 criteria: Waist circumference ≥85 cm (male) or 80 cm (female); TG ≥150 mg/dL or with lipid-lowering treatment; HDL<40 mg/dL (male) /50 mg/dL (female);SBP ≥ 130 mmHg and / or DBP ≥ 85 mmHg and / or with diagnosed hypertension and anti-hypertensive treatment; fasting glucose ≥ 5.6 mmol/L and / or with diagnosed type 2 diabetes and hypoglycemic treatment. (If with type 2 diabetes, the process of the disease should not exceed 6 years, with the level of C-P ≥3/4 of the lower limit of limit; if with hypertension, BP ≤ 180/110 mmHg without anti-hypertensive agent, or BP ≤160/100 mmHg with 1-2 kinds of anti-hypertensive agents, or BP ≤140/90 mmHg with 3-4 kinds of anti-hypertensive agents; if with hyper-triglyceridemia, TG ≤ 11.2 mmol/L without lipid-lowering agent, or TG ≤ 5.6 mmol/L with lipid-lowering agent.)
  • Han Chinese
  • Willingness to participate

Exclusion Criteria:

  • Participants with metabolic syndrome caused by other secondary factors (genetic diseases related to obesity and hyperlipidemia, Cushing's syndrome, drug-induced obesity and etc.);
  • Participants whose body weight fluctuated by more than 5 kg in the last 6 months; who trying to lose weight in the last 3 months; Who had used anti-obesity drugs, oral contraceptive, or glucocorticoids in the last 3 months;
  • Participants with Type 1 diabetes or gestational diabetes or other types of diabetes;
  • Participants with BP ≥ 180/110 mmHg, or malignant hypertension;
  • Participants with previous severe gastrointestinal diseases;
  • Participants with significant dysfunction of heart, liver, kidney and systemic organs (NYHA Class III or IV; ALT and / or AST ≥ 5 times the normal upper limit; GFR < 60 ml/min) or with malignant tumor;
  • Participants with drug abuse or alcohol addiction; with serious mental and neurological disorders;
  • Pregnant or lactating women; Those who have planned to give birth within the past 1 year;
  • Participants with special dietary requirements, or with soy products, milk and other daily food allergies;
  • Participants in other clinical trials.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pengfei Shan, MD, PhD 86-0571-87783777 pengfeishan@zju.edu.cn
Contact: Yuezhong Ren, MD +86-057187783777
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04116905
Other Study ID Numbers  ICMJE LIMS
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 Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE
  • Zhejiang Provincial People's Hospital
  • Zhejiang Xiaoshan hospital
  • The 907th PLA joint logistic support force hospital
  • Xiangya Hospital of Central South University
  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • First affiliated hospital of Nanhua University
  • General hospital of the PLA central theater
  • Shanghai First People's hospital, Fudan University
  • First affiliated hospital of Nanchang University
  • Second Affiliated Hospital of Nanchang University
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital, Henan University of Science and Technology
  • Second people's hospital of Guangdong province
Investigators  ICMJE
Principal Investigator: Pengfei Shan, MD, PhD Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator: Yuezhong Ren, MD Second Affiliated Hospital, School of Medicine, Zhejiang University
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date September 2019

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