Metabolic SyndromeNCT06182618
Retrospective Analysis for Patients With Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The incidence of metabolic syndrome and related diseases is gradually increasing, and diet and medication are currently common outpatient treatment methods. This study retrospectively analyzes the clinical data of patients with metabolic syndrome and related diseases who have visited our outpatient department in the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- dietary, semaglutide or/and metformin
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jan 2024
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This was a retrospective study of the weight loss effect in 1 to 3 months in overweight or obese individuals at the department of clinical nutrition in the Second Affiliated Hospital of Zhejiang University, School of Medicine in China between 1 January 2020 and 1 Janu-ary 2024.
Who may be able to join
- individuals who had at least a 2 follow up visits with a BMI of 24 or more with the pri-mary goal of losing weight.
Who cannot join
- patients did not follow-up on a monthly basis;
- patients followed-up less than 1 times within 3 months;
- patients having incomplete data;
- patients changing their interventions during fol-low-ups
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
wang leilei, 15968860233, 2513118@zju.edu.cn
About this study
Official title: Retrospective Analysis of Outpatient Intervention Effects in Patients With Metabolic Syndrome
The incidence of metabolic syndrome and related diseases is gradually increasing, and diet and medication are currently common outpatient treatment methods. This study retrospectively analyzes the clinical data of patients with metabolic syndrome and related diseases who have visited our outpatient department in the past 10 years, compares the therapeutic effects of different treatment methods on their blood glucose, blood lipids, blood pressure, uric acid, and body composition, and provides evidence support for clinical treatment.
- Conditions
- Metabolic Syndrome
- Being tested
- dietary, semaglutide or/and metformin
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary, semaglutide or/and metforminOther
patients were prescribed dietary and pharmaceuticals for weight loss
| Study group | Role | What they receive |
|---|---|---|
| low-carbohydrate diet | 20-30% carbohydrates, 40-45%fat, and 30-40%protein Receives: Other: dietary, semaglutide or/and metformin | |
| balanced diet | 50-65% carbohydrate, 20-30% fat and 10-20% protein Receives: Other: dietary, semaglutide or/and metformin | |
| pharmacotherapy | semaglutide (1mg per week) or/and metformin (o.5g three times a day) Receives: Other: dietary, semaglutide or/and metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Weight was measured through multi-frequency bioelectrical impedance analysis InBody 720 (Bio Space Co., Seoul, Korea) at various time points
Measured: 0month/1month/2months/3 months
Secondary outcomes (2)
visceral fat area(VFA)
VFA was measured through multi-frequency bioelectrical impedance analysis InBody 720 (Bio Space Co., Seoul, Korea) at various time points
Measured: 0month/1month/2months/3 months
skeletal muscle mass(SMM)
SMM was measured through multi-frequency bioelectrical impedance analysis InBody 720 (Bio Space Co., Seoul, Korea) at various time points
Measured: 0month/1month/2months/3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start1 Jun 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182618
- Sponsor's protocol ID
- 2023-1042
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang LL, Wang LL, Liu XC, Hu HY, Li HX, Wei W, Du Q, Yan HH. Comparison of weight loss induced by dietary and pharmaceuticals in individuals with overweight and obesity: a retrospective study. Br J Nutr. 2024 Dec 28;132(12):1611-1620. doi: 10.1017/S0007114524002629. Epub 2024 Nov 14.
PubMed 39540270
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Outpatient Intervention Effects in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06182618
- Acronym / sponsor ID
- 2023-1042
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 27 Dec 2023 (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.
The incidence of metabolic syndrome and related diseases is gradually increasing, and diet and medication are currently common outpatient treatment methods. This study retrospectively analyzes the clinical data of patients with metabolic syndrome and related diseases who have visited our outpatient department in the past 10 years, compares the therapeutic effects of different treatment methods on their blood glucose, blood lipids, blood pressure, uric acid, and body composition, and provides evidence support for clinical treatment.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-carbohydrate diet | – | Other: dietary, semaglutide or/and metformin20-30% carbohydrates, 40-45%fat, and 30-40%protein |
| balanced diet | – | Other: dietary, semaglutide or/and metformin50-65% carbohydrate, 20-30% fat and 10-20% protein |
| pharmacotherapy | – | Other: dietary, semaglutide or/and metforminsemaglutide (1mg per week) or/and metformin (o.5g three times a day) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective study of the weight loss effect in 1 to 3 months in overweight or obese individuals at the department of clinical nutrition in the Second Affiliated Hospital of Zhejiang University, School of Medicine in China between 1 January 2020 and 1 Janu-ary 2024.
Key inclusion criteria (1 listed)
- individuals who had at least a 2 follow up visits with a BMI of 24 or more with the pri-mary goal of losing weight.
Key exclusion criteria (4 listed)
- patients did not follow-up on a monthly basis;
- patients followed-up less than 1 times within 3 months;
- patients having incomplete data;
- patients changing their interventions during fol-low-ups
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 |
|---|---|---|
| dietary, semaglutide or/and metforminpatients were prescribed dietary and pharmaceuticals for weight loss | Other | balanced diet, low-carbohydrate diet, pharmacotherapy |
Primary outcome
weight
Time frame: 0month/1month/2months/3 months
Weight was measured through multi-frequency bioelectrical impedance analysis InBody 720 (Bio Space Co., Seoul, Korea) at various time points
2 secondary outcomes
visceral fat area(VFA)
Time frame: 0month/1month/2months/3 months
skeletal muscle mass(SMM)
Time frame: 0month/1month/2months/3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Derived from this study: PubMed 39540270Wang LL, Wang LL, Liu XC, Hu HY, Li HX, Wei W, Du Q, Yan HH. Comparison of weight loss induced by dietary and pharmaceuticals in individuals with overweight and obesity: a retrospective study. Br J Nutr. 2024 Dec 28;132(12):1611-1620. doi: 10.1017/S0007114524002629. Epub 2024 Nov 14.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact leilei wang (0571-87783851, 2513118@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 0month/1month/2months/3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06182618, which also lists 1 linked publication.
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 27 Dec 2023.