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Intensive Lifestyle Intervention for Remission of Metabolic Syndrome (LIMS)

Primary Purpose

Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intensive Lifestyle Intervention
Conventional Treatment
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metablolic syndrome, remission, life style, weight loss

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive Lifestyle Intervention

Conventional Treatment

Arm Description

Participants in the intensive lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain a 15% weight loss.

The conventional treatment arm provides group sessions on metabolic syndrome management and social support, aimed at a 5% weight loss.

Outcomes

Primary Outcome Measures

The remission rate of metabolic syndrome
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%
The proportion of participants maintaining a weight loss of more than 15%.

Secondary Outcome Measures

Remission of hypertension
The proportion with BP<130/85mmHg or BP<140/90mmHg without medication.
Remission of hyperglycemia
The proportion with fasting blood glucose <5.6 mmol/L without medication.
Remission of hypertriglyceridemia
The proportion with blood triglyceride<150 mg/dl without medication.
Remission of low HDL-C
The proportion with HDL-C≥40 mg/dl in male or ≥50 mg/dl in female without medication.
Remission of central obesity
The proportion with waist circumference <85 cm in male or <80 cm in female.

Full Information

First Posted
September 16, 2019
Last Updated
May 12, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Zhejiang Provincial People's Hospital, Zhejiang 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, The 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
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1. Study Identification

Unique Protocol Identification Number
NCT04116905
Brief Title
Intensive Lifestyle Intervention for Remission of Metabolic Syndrome
Acronym
LIMS
Official Title
Intensive Lifestyle Intervention for Remission of Metabolic Syndrome in Overweight or Obese Han Chinese Population
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Zhejiang Provincial People's Hospital, Zhejiang 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, The 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metablolic syndrome, remission, life style, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive Lifestyle Intervention
Arm Type
Experimental
Arm Description
Participants in the intensive lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain a 15% weight loss.
Arm Title
Conventional Treatment
Arm Type
Active Comparator
Arm Description
The conventional treatment arm provides group sessions on metabolic syndrome management and social support, aimed at a 5% weight loss.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Lifestyle Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
The remission rate of metabolic syndrome
Description
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.
Time Frame
12 months
Title
The proportion of participants with wight loss exceeding 15%
Description
The proportion of participants maintaining a weight loss of more than 15%.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Remission of hypertension
Description
The proportion with BP<130/85mmHg or BP<140/90mmHg without medication.
Time Frame
12 months
Title
Remission of hyperglycemia
Description
The proportion with fasting blood glucose <5.6 mmol/L without medication.
Time Frame
12 months
Title
Remission of hypertriglyceridemia
Description
The proportion with blood triglyceride<150 mg/dl without medication.
Time Frame
12 months
Title
Remission of low HDL-C
Description
The proportion with HDL-C≥40 mg/dl in male or ≥50 mg/dl in female without medication.
Time Frame
12 months
Title
Remission of central obesity
Description
The proportion with waist circumference <85 cm in male or <80 cm in female.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pengfei Shan, MD, PhD
Phone
86-0571-87783777
Email
pengfeishan@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuezhong Ren, MD
Phone
+86-057187783777
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pengfei Shan, MD, PhD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuezhong Ren, MD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengfei Shan, MD, PhD
Phone
86-057187783777
Email
pengfeishan@zju.edu.cn

12. IPD Sharing Statement

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Intensive Lifestyle Intervention for Remission of Metabolic Syndrome

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