Lifestyle overhaul may reverse metabolic syndrome in overweight individuals
NCT ID NCT04116905
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a structured, intensive lifestyle program could help overweight or obese people with metabolic syndrome achieve remission. 68 participants followed a program aiming for 15% weight loss. The goal was to see if this approach could reduce the number of metabolic syndrome risk factors and improve health without long-term medication.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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68 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Oct 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ≥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 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 ≥ 4 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
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