ObesityNCT02226471
Serum CTRP3 and RBP4 Levels in Obesity and Hypertension
An observational study of Obesity and Hypertension, run by Third Military Medical University.
Trial summary
Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines may play important roles in the pathogenesis of obesity, which are a link between obesity and obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein 4 (RBP4) are novel adipokine that modulates… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Feb 2014
- How long will I take part?
- 3 Years
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We consecutively selected 2100 Chinese subjects from the general population who had undergone medical check-ups at the Southwest Hospital Medical Center at the Third Military Medical University
Who may be able to join
- Hypertension not taking antihypertensive medications
- Obesity not taking anti-obese or lipid-lowering medications
Who cannot join
- Heart failure;
- pregnant or lactating
- diabetes
- thyroid disease
- fractures
- osteoporosis
- tumors;
About this study
Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines may play important roles in the pathogenesis of obesity, which are a link between obesity and obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein 4 (RBP4) are novel adipokine that modulates the action of insulin in various diseases. This study addressed the relationship between CTRP3, RBP4 and IR in newly diagnosed obesity and essential hypertension.
Read the detailed description
Serum CTRP3 and RBP4, anthropometric and metabolic parameters were determined in 480 newly diagnosed obesity and essential hypertensive patients not taking anti-obese and antihypertensive medications and 66 normal weight (NW) and normotensive subjects. All subjects were divided into two groups depending on body mass index (BMI), including NW group and obesity group, and then four subgroups were divided according to obesity and hypertension, including NW-normal blood pressure subgroup (NW-NBP), NW-hypertension subgroup (NW-HTN), obese-normal blood pressure subgroup (OB-NBP), obese-hypertension subgroup (OB-HTN).
- Conditions
- Obesity, Hypertension
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NW-NBP group | normal weight and blood pressure subjects | |
| NW-HTN group | Normal weight with hypertension subjects | |
| OB-NBP group | obese-normal blood pressure subjects | |
| OB-HTN group | Obese-hypertension subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTRP3 and RBP4 levels were measured in obesity and hypertension
531 subjects were required to fast overnight before the physical examination.Blood pressure was measured three times, each 2 min apart on the upper arm using a mercury sphygmomanometer in a seated, resting position after 10 minutes of rest; the mean of the three measurements was used for the statistical analysis.Weight, height and hip and waist circumference (WC), were measured. BMI was calculated as body weight in kilograms divided by the square of height (m2). WHR was calculated as the waist to hip circumference.
Overnight fasting blood samples were collected in tubes containing liquid EDTA; the samples were centrifuged at -4°C and maintained at -80°C until assayed. FBG was assayed using the glucose oxidase method. UA, TC, TG, LDL-C and HDL-C concentrations were determined enzymatically.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionFeb 2014
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 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deng Wu Quan, Third Military Medical University
- Investigators
- Deng Wuquan, PHD, Study director, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226471
- Sponsor's protocol ID
- SW1000
- Status last verified
- Aug 2014
- First submitted
- 24 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deng W, Li C, Zhang Y, Zhao J, Yang M, Tian M, Li L, Zheng Y, Chen B, Yang G. Serum C1q/TNF-related protein-3 (CTRP3) levels are decreased in obesity and hypertension and are negatively correlated with parameters of insulin resistance. Diabetol Metab Syndr. 2015 Apr 10;7:33. doi: 10.1186/s13098-015-0029-0. eCollection 2015.
PubMed 25878729
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum CTRP3 and RBP4 Levels in Obesity and Hypertension
- ClinicalTrials.gov ID
- NCT02226471
- Acronym / sponsor ID
- SW1000
- Conditions
- Obesity, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Aug 2014 (estimated)
- 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.
Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines may play important roles in the pathogenesis of obesity, which are a link between obesity and obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein 4 (RBP4) are novel adipokine that modulates the action of insulin in various diseases. This study addressed the relationship between CTRP3, RBP4 and IR in newly diagnosed obesity and essential hypertension.
Detailed description
Serum CTRP3 and RBP4, anthropometric and metabolic parameters were determined in 480 newly diagnosed obesity and essential hypertensive patients not taking anti-obese and antihypertensive medications and 66 normal weight (NW) and normotensive subjects. All subjects were divided into two groups depending on body mass index (BMI), including NW group and obesity group, and then four subgroups were divided according to obesity and hypertension, including NW-normal blood pressure subgroup (NW-NBP), NW-hypertension subgroup (NW-HTN), obese-normal blood pressure subgroup (OB-NBP), obese-hypertension subgroup (OB-HTN).
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NW-NBP group | – | –normal weight and blood pressure subjects |
| NW-HTN group | – | –Normal weight with hypertension subjects |
| OB-NBP group | – | –obese-normal blood pressure subjects |
| OB-HTN group | – | –Obese-hypertension subjects |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We consecutively selected 2100 Chinese subjects from the general population who had undergone medical check-ups at the Southwest Hospital Medical Center at the Third Military Medical University
Key inclusion criteria (2 listed)
- Hypertension not taking antihypertensive medications
- Obesity not taking anti-obese or lipid-lowering medications
Key exclusion criteria (7 listed)
- Heart failure;
- pregnant or lactating
- diabetes
- thyroid disease
- fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CTRP3 and RBP4 levels were measured in obesity and hypertension
Time frame: 1 year
531 subjects were required to fast overnight before the physical examination.Blood pressure was measured three times, each 2 min apart on the upper arm using a mercury sphygmomanometer in a seated, resting position after 10 minutes of rest; the mean of the three measurements was used for the statistical analysis.Weight, height and hip and waist circumference (WC), were measured. BMI was calculated as body weight in kilograms divided by the square of height (m2). WHR was calculated as the waist to hip circumference. Overnight fasting blood samples were collected in tubes containing liquid EDTA; the samples were centrifuged at -4°C and maintained at -80°C until assayed. FBG was assayed using the glucose oxidase method. UA, TC, TG, LDL-C and HDL-C concentrations were determined enzymatically.
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 27 Aug 2014.
- Derived from this study: PubMed 25878729Deng W, Li C, Zhang Y, Zhao J, Yang M, Tian M, Li L, Zheng Y, Chen B, Yang G. Serum C1q/TNF-related protein-3 (CTRP3) levels are decreased in obesity and hypertension and are negatively correlated with parameters of insulin resistance. Diabetol Metab Syndr. 2015 Apr 10;7:33. doi: 10.1186/s13098-015-0029-0. eCollection 2015.
- Implication of Progranulin and C1q/TNF-Related Protein-3 (CTRP3) on Inflammation and Atherosclerosis in Subjects with or without Metabolic SyndromeLink provided by the sponsor.
- Identification of Adipokine Clusters Related to Parameters of Fat Mass, Insulin Sensitivity and InflammationLink provided by the sponsor.
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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.
Deng Wuquan, PHD study director
Southwest Hospital, China
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Hypertension, run by Third Military Medical University.
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 2 inclusion and 7 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 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
CTRP3 and RBP4 levels were measured in obesity and hypertension (time frame: 1 year). 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 NCT02226471, 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 Aug 2014.