Metabolic SyndromeINSLIMSNCT04116905
Intensive Lifestyle Intervention for Remission of Metabolic Syndrome
A study testing Intensive Lifestyle Intervention and Conventional Treatment in people with Metabolic Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a randomized, prospective clinical trial investigating metabolic syndrome in overweight or obese Chinese individuals. The study aims to evaluate the efficacy of a structured intensive lifestyle intervention program in achieving significant weight reduction (targeting 15% weight loss) and promoting metabolic… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Intensive Lifestyle Intervention and Conventional Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 ≥1.7 mmol/L or with lipid-lowering treatment; HDL<1.04 mmol/L(male) /1.3 mmol/L (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
Who cannot join
- 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 ≥ 4 times the normal upper limit; GFR < 60 ml/min) or with malignant tumor;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Intensive Lifestyle Interventions for Remission of Metabolic Syndrome in Overweight or Obese Individuals
This is a randomized, prospective clinical trial investigating metabolic syndrome in overweight or obese Chinese individuals. The study aims to evaluate the efficacy of a structured intensive lifestyle intervention program in achieving significant weight reduction (targeting 15% weight loss) and promoting metabolic syndrome remission. Additionally, the research will explore the potential mechanisms underlying these therapeutic effects. Furthermore, this study enables phased presentation of the findings.
Read the detailed description
Background:
Metabolic syndrome is a global public health concern, with prevalence rates ranging from 10% to 84% across different populations. It is strongly associated with multiple chronic non-communicable diseases, including type 2 diabetes, cardiovascular diseases, non-alcoholic fatty liver disease, polycystic ovary syndrome, and certain cancers. Notably, obesity plays a central role in the development of metabolic syndrome, and substantial evidence supports the benefits of significant weight loss in improving its components. Currently, there is a lack of research on lifestyle interventions aimed at weight loss to alleviate metabolic syndrome in affected populations.
Study Design:
This study is a single-center, prospective, randomized controlled trial. Metabolic syndrome (MetS) subjects aged 18-60 years were enrolled and randomly assigned to either an intensive lifestyle intervention group (a low-carbohydrate diet combined with physical exercise, target weight loss of 15%) or a conventional lifestyle intervention group ( energy-restricted diet combined with physical exercise, target weight loss of 7%). Participants underwent a 5-month weight-loss intervention (with monthly follow-ups) followed by a 7-month weight-maintenance phase (with follow-ups every 2 months). During the follow-up period, anthropometric and laboratory parameters were regularly monitored.
- Conditions
- Metabolic Syndrome
- Being tested
- Intensive Lifestyle Intervention, Conventional Treatment
- Keywords
- Metablolic syndrome, remission, life style, weight loss
- Medical subject headings
- Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Lifestyle InterventionBehavioural
The intensive lifestyle intervention program employs a structured, multi-component approach under professional supervision to achieve and sustain 15% weight reduction from baseline. This 12-month intervention features:
- A weight loss phase (months 1-5) incorporating: Individualized calorie restriction using partial meal replacement (carbohydrate energy supply ratio is 20~25%, and the daily calorie intake is 22.5*70% kcal/kg/d); exercise recommends at least 150 min of moderate intensity and 2 to 3 resistance training per week; with monthly follow-ups.
- A maintenance phase (months 6-12) focusing on: A Healthy, balanced diet, total daily calorie intake is 20-25 kcal/kg/d; exercise recommendations at least 150 minutes of moderate intensity and 2-3 resistance training per week; with follow-ups every 2 months.
- Digital health integration: Mobile application-based monitoring of metabolic parameters; real-time feedback and adherence tracking.
Conventional TreatmentBehavioural
The conventional treatment arm receive standardized metabolic syndrome management through monthly group education sessions and peer support, with a target of 7% weight reduction from baseline. The program incorporates:
- A weight loss phase (months 1-5) incorporating: Structured lifestyle education; limit the total energy diet (total daily calorie intake is 22.5*85% kcal/kg/d), with carbohydrates, fat, proteins accounting for 45-55%, 20-30%, and 20-30%, respectively, for the daily energy intake.; physical activity(150 min medium intensity exercise and 2 to 3 resistance training); with monthly follow-ups;
- A maintenance phase (months 6-12) focusing on: Healthy balanced diet, total daily calorie intake is 20~25 kcal/kg/d; physical activity(150 min medium intensity exercise and 2 to 3 resistance training);with follow-ups every 2 months;
- Digital health integration:
Mobile application-based monitoring of metabolic parameters; real-time feedback and adherence tracking.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Lifestyle Intervention | Experimental | Participants randomized to the intensive lifestyle intervention arm will receive a structured, multi-component program consisting of both individualized counseling and group-based sessions. This intervention is specifically designed to facilitate achievement of a clinically significant 15% weight reduction and support long-term weight maintenance." Receives: Behavioral: Intensive Lifestyle Intervention |
| Conventional Treatment | Active comparator | Participants in the conventional treatment arm receive structured group-based education sessions focusing on metabolic syndrome management principles and peer support, with the therapeutic goal of achieving a modest 7% weight reduction Receives: Behavioral: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The remission rate of metabolic syndrome
Participants are considered to have achieved metabolic syndrome remission when they meet ≤2 of the following 5 diagnostic criteria:
- Waist circumference ≥85 cm (men) / ≥80 cm (women);
- Fasting triglycerides ≥1.7 mmol/L or current lipid-lowering therapy;
- HDL cholesterol <1.04 mmol/L (men) / <1.30 mmol/L (women);
- Systolic BP ≥130 mmHg and/or diastolic BP ≥85 mmHg, or diagnosed hypertension with antihypertensive treatment;
- Fasting glucose ≥5.6 mmol/L, or diagnosed type 2 diabetes with glucose-lowering treatment.
Remission is defined as sustained resolution of ≥3 criteria.
Measured: 12 months
The proportion of participants achieving 15% weight loss from baseline
The proportion of participants achieving 15% weight loss from baseline
Measured: 12 months
Secondary outcomes (5)
Remission of hypertension
The proportion of participants achieving target blood pressure control (either <130/85 mmHg or <140/90 mmHg) without antihypertensive medication.
Measured: 12 months
Remission of hyperglycemia
The proportion of participants achieving fasting plasma glucose <5.6 mmol/L without glucose-lowering medication.
Measured: 12 months
Remission of hypertriglyceridemia
The proportion of participants achieving triglyceride levels <1.7 mmol/L without lipid-lowering therapy.
Measured: 12 months
Remission of low HDL-C
The sex-specific proportion achieving therapeutic HDL-C targets (≥1.04 mmol/L in males; ≥1.30 mmol/L in females) without lipid-modifying therapy.
Measured: 12 months
Remission of central obesity
Proportion meeting gender-stratified waist circumference criteria (males <85 cm; females <80 cm).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Oct 2020
- Primary completion31 Aug 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pengfei Shan, MD, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineYuezhong Ren, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116905
- Sponsor's protocol ID
- LIMS
- Acronym
- INSLIMS
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Lifestyle Interventions for Remission of Metabolic Syndrome in Overweight or Obese Individuals
- ClinicalTrials.gov ID
- NCT04116905
- Acronym / sponsor ID
- INSLIMS / LIMS
- Conditions
- Metabolic Syndrome
- Keywords
- Metablolic syndrome, remission, life style, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, prospective clinical trial investigating metabolic syndrome in overweight or obese Chinese individuals. The study aims to evaluate the efficacy of a structured intensive lifestyle intervention program in achieving significant weight reduction (targeting 15% weight loss) and promoting metabolic syndrome remission. Additionally, the research will explore the potential mechanisms underlying these therapeutic effects. Furthermore, this study enables phased presentation of the findings.
Detailed description
Background:
Metabolic syndrome is a global public health concern, with prevalence rates ranging from 10% to 84% across different populations. It is strongly associated with multiple chronic non-communicable diseases, including type 2 diabetes, cardiovascular diseases, non-alcoholic fatty liver disease, polycystic ovary syndrome, and certain cancers. Notably, obesity plays a central role in the development of metabolic syndrome, and substantial evidence supports the benefits of significant weight loss in improving its components. Currently, there is a lack of research on lifestyle interventions aimed at weight loss to alleviate metabolic syndrome in affected populations.
Study Design:
This study is a single-center, prospective, randomized controlled trial. Metabolic syndrome (MetS) subjects aged 18-60 years were enrolled and randomly assigned to either an intensive lifestyle intervention group (a low-carbohydrate diet combined with physical exercise, target weight loss of 15%) or a conventional lifestyle intervention group ( energy-restricted diet combined with physical exercise, target weight loss of 7%). Participants underwent a 5-month weight-loss intervention (with monthly follow-ups) followed by a 7-month weight-maintenance phase (with follow-ups every 2 months). During the follow-up period, anthropometric and laboratory parameters were regularly monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Lifestyle Intervention | Experimental | Behavioral: Intensive Lifestyle InterventionParticipants randomized to the intensive lifestyle intervention arm will receive a structured, multi-component program consisting of both individualized counseling and group-based sessions. This intervention is specifically designed to facilitate achievement of a clinically significant 15% weight reduction and support long-term weight maintenance." |
| Conventional Treatment | Active comparator | Behavioral: Conventional TreatmentParticipants in the conventional treatment arm receive structured group-based education sessions focusing on metabolic syndrome management principles and peer support, with the therapeutic goal of achieving a modest 7% weight reduction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 ≥1.7 mmol/L or with lipid-lowering treatment; HDL<1.04 mmol/L(male) /1.3 mmol/L (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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Lifestyle InterventionThe intensive lifestyle intervention program employs a structured, multi-component approach under professional supervision to achieve and sustain 15% weight reduction from baseline. This 12-month intervention features: 1. A weight loss phase (months 1-5) incorporating: Individualized calorie restriction using partial meal replacement (carbohydrate energy supply ratio is 20~25%, and the daily calorie intake is 22.5*70% kcal/kg/d); exercise recommends at least 150 min of moderate intensity and 2 to 3 resistance training per week; with monthly follow-ups. 2. A maintenance phase (months 6-12) focusing on: A Healthy, balanced diet, total daily calorie intake is 20-25 kcal/kg/d; exercise recommendations at least 150 minutes of moderate intensity and 2-3 resistance training per week; with follow-ups every 2 months. 3. Digital health integration: Mobile application-based monitoring of metabolic parameters; real-time feedback and adherence tracking. | Behavioural | Intensive Lifestyle Intervention |
| Conventional TreatmentThe conventional treatment arm receive standardized metabolic syndrome management through monthly group education sessions and peer support, with a target of 7% weight reduction from baseline. The program incorporates: 1. A weight loss phase (months 1-5) incorporating: Structured lifestyle education; limit the total energy diet (total daily calorie intake is 22.5*85% kcal/kg/d), with carbohydrates, fat, proteins accounting for 45-55%, 20-30%, and 20-30%, respectively, for the daily energy intake.; physical activity(150 min medium intensity exercise and 2 to 3 resistance training); with monthly follow-ups; 2. A maintenance phase (months 6-12) focusing on: Healthy balanced diet, total daily calorie intake is 20~25 kcal/kg/d; physical activity(150 min medium intensity exercise and 2 to 3 resistance training);with follow-ups every 2 months; 3. Digital health integration: Mobile application-based monitoring of metabolic parameters; real-time feedback and adherence tracking. | Behavioural | Conventional Treatment |
Primary outcome
The remission rate of metabolic syndrome
Time frame: 12 months
Participants are considered to have achieved metabolic syndrome remission when they meet ≤2 of the following 5 diagnostic criteria: 1. Waist circumference ≥85 cm (men) / ≥80 cm (women); 2. Fasting triglycerides ≥1.7 mmol/L or current lipid-lowering therapy; 3. HDL cholesterol <1.04 mmol/L (men) / <1.30 mmol/L (women); 4. Systolic BP ≥130 mmHg and/or diastolic BP ≥85 mmHg, or diagnosed hypertension with antihypertensive treatment; 5. Fasting glucose ≥5.6 mmol/L, or diagnosed type 2 diabetes with glucose-lowering treatment. Remission is defined as sustained resolution of ≥3 criteria.
The proportion of participants achieving 15% weight loss from baseline
Time frame: 12 months
The proportion of participants achieving 15% weight loss from baseline
5 secondary outcomes
Remission of hypertension
Time frame: 12 months
Remission of hyperglycemia
Time frame: 12 months
Remission of hypertriglyceridemia
Time frame: 12 months
Remission of low HDL-C
Time frame: 12 months
Remission of central obesity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pengfei Shan, MD, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Yuezhong Ren, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Lifestyle Intervention and Conventional Treatment in people with Metabolic Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The remission rate of metabolic syndrome (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.