ObesityNCT06391320
Obesity Queue Database
An observational study of Obesity, run by RenJi Hospital at 1 site in China.
Trial summary
To establish an obesity specific disease cohort database and form a special disease cohort, so as to provide guarantee for carrying out high-quality real-world clinical research and clinical research. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- other
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with obesity, aged 18-75 years, who met the diagnostic criteria for simple obesity and did not participate in any drug clinical trials within 3 months prior to inclusion.
Who may be able to join
- Patients aged 18-75 years with simple obesity. Simple obesity diagnosis criteria: meet one of the following conditions
- BMI≥25 kg/m2
- Waist circumference for male/female ≥90/80 cm
- Waist-to-hip ratio: 0.9 (male); 0.85 (female)
Who cannot join
- Patients aged 18-75 years with simple obesity. Simple obesity diagnosis criteria: meet one of the following conditions
- BMI≥25 kg/m2
- Waist circumference for male/female ≥90/80 cm
- Waist-to-hip ratio: 0.9 (male); 0.85 (female)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai
Jiang Yue, +86 189 1815 2626, rjnfm3083@163.com
About this study
To establish an obesity specific disease cohort database and form a special disease cohort, so as to provide guarantee for carrying out high-quality real-world clinical research and clinical research.
- Conditions
- Obesity
- Being tested
- other
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
otherOther
Observational studies do not involve intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-PDFF intraperitoneal fat content, fasting and postprandial blood glucose, insulin, C-peptide, glycated hemoglobin, body weight, waist circumference, hip circumference
For a specialized outpatient clinic for obesity, follow-ups should be conducted at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. During the trial period and the post-trial observation period, relevant safety indicators must be documented, analyzed statistically, and reported.
Measured: 5 years
Secondary outcomes (1)
Intestinal flora components, glucagon, gastrointestinal hormones GLP-1 and GIP, inflammatory immune indicators, etc
For a specialized outpatient clinic for obesity, follow-ups should be conducted at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. During the trial period and the post-trial observation period, relevant safety indicators must be documented, analyzed statistically, and reported.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391320
- Sponsor's protocol ID
- LY2023-212-B
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Queue Database
- ClinicalTrials.gov ID
- NCT06391320
- Acronym / sponsor ID
- LY2023-212-B
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Apr 2024 (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.
To establish an obesity specific disease cohort database and form a special disease cohort, so as to provide guarantee for carrying out high-quality real-world clinical research and clinical research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity, aged 18-75 years, who met the diagnostic criteria for simple obesity and did not participate in any drug clinical trials within 3 months prior to inclusion.
Key inclusion criteria (4 listed)
- Patients aged 18-75 years with simple obesity. Simple obesity diagnosis criteria: meet one of the following conditions
Key exclusion criteria (4 listed)
- Patients aged 18-75 years with simple obesity. Simple obesity diagnosis criteria: meet one of the following conditions
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 |
|---|---|---|
| otherObservational studies do not involve intervention | Other | – |
Primary outcome
MRI-PDFF intraperitoneal fat content, fasting and postprandial blood glucose, insulin, C-peptide, glycated hemoglobin, body weight, waist circumference, hip circumference
Time frame: 5 years
For a specialized outpatient clinic for obesity, follow-ups should be conducted at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. During the trial period and the post-trial observation period, relevant safety indicators must be documented, analyzed statistically, and reported.
1 secondary outcome
Intestinal flora components, glucagon, gastrointestinal hormones GLP-1 and GIP, inflammatory immune indicators, etc
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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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.
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 Obesity, run by RenJi Hospital 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 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: looking for participants now, as of the sponsor's last update on 30 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Ma (+86 158 0098 3436, cherry1996@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI-PDFF intraperitoneal fat content, fasting and postprandial blood glucose, insulin, C-peptide, glycated hemoglobin, body weight, waist circumference, hip circumference (time frame: 5 years). 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 30 Apr 2024.