Spinal Cord InjuriesNCT05997251
The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to reveal the relationship of DASH and Mediterranean diet score with anthropometric measurements and serum adiponectin level in individuals with spinal cord injury. This research was planned as a cross-sectional, case-control study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Keeping a 1-day food consumption record by the patient and Measurement of adiponectin level
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Mar 2022
- 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: Patients admitted to hospital Healthy population from patient care givers of hospital staff
Who may be able to join
- Having spent at least 6 months after spinal cord injury
- 1st motor neuron injury
- Being between the ages of 18-65
- Giving consent to participate in the study Inclusion criteria (Control group)
- Being between the ages of 18-65
- Giving consent to participate in the study
Who cannot join
- Having an additional disease to the spinal cord injury
- Having a 2nd motor neuron lesion
- Having any disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital
Ankara
About this study
The aim of this study is to reveal the relationship of DASH and Mediterranean diet score with anthropometric measurements and serum adiponectin level in individuals with spinal cord injury. This research was planned as a cross-sectional, case-control study. With the data to be obtained from the research, information will be obtained about the hormonal or biochemical basis of metabolic disorders such as atherosclerosis and insulin resistance that may occur in individuals with spinal cord injury in the long term.
20 individuals with Spinal Cord Injury will be included in the study, and the results of the patients will be compared with 20 healthy individuals. In order to determine the food consumption status of the patients, a 1-day food consumption record will be requested. DASH diet score and Mediterranean diet score will be calculated from dietary records. After 8 hours of fasting, 3 ml of peripheral blood will be taken for the measurement of adiponectin between 08:00 and 09:00 in the morning from the individuals in the study and control groups. Adiponectin level will be measured and its correlation with DASH diet score and Mediterranean diet score will be examined.
- Conditions
- Spinal Cord Injuries
- Being tested
- Keeping a 1-day food consumption record by the patient, Measurement of adiponectin level
- Keywords
- Adiponectin
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keeping a 1-day food consumption record by the patientOther
Checking and receiving the 1-day food consumption record recorded by the patient by the researcher
Measurement of adiponectin levelOther
Adiponectin level will be measured for each group
| Study group | Role | What they receive |
|---|---|---|
| Patients with spinal cord injury | Not described Receives: Other: Keeping a 1-day food consumption record by the patient; Other: Measurement of adiponectin level | |
| Healthy group | Not described Receives: Other: Keeping a 1-day food consumption record by the patient; Other: Measurement of adiponectin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adiponectin level
Adiponectin level will be measured from peripheral blood
Measured: Will be measured at inclusion
DASH diet score
Will be measured at inclusion from one day dietary record
Measured: Will be measured at inclusion from one day dietary record
Mediterrenian diet score
Will be measured at inclusion from one day dietary record
Measured: Will be measured at inclusion from one day dietary record
Secondary outcomes (6)
Whole blood count
Will be measured at inclusion
Measured: Will be measured at inclusion
Fasting blood glucose
Will be measured at inclusion
Measured: Will be measured at inclusion
Total cholesterol
Will be measured at inclusion
Measured: Will be measured at inclusion
LDL
Will be measured at inclusion
Measured: Will be measured at inclusion
HDL
Will be measured at inclusion
Measured: Will be measured at inclusion
TG
Will be measured at inclusion
Measured: Will be measured at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Adıgüzel, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997251
- Sponsor's protocol ID
- E2-21-89
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang YH, Huang TS, Liang HW, Su TC, Chen SY, Wang TD. Fasting serum levels of adiponectin, ghrelin, and leptin in men with spinal cord injury. Arch Phys Med Rehabil. 2005 Oct;86(10):1964-8. doi: 10.1016/j.apmr.2005.04.017.
PubMed 16213239Ekmekci H, Ekmekci OB. The role of adiponectin in atherosclerosis and thrombosis. Clin Appl Thromb Hemost. 2006 Apr;12(2):163-8. doi: 10.1177/107602960601200203.
PubMed 16708117O'Brien LC, Graham ZA, Chen Q, Lesnefsky EJ, Cardozo C, Gorgey AS. Plasma adiponectin levels are correlated with body composition, metabolic profiles, and mitochondrial markers in individuals with chronic spinal cord injury. Spinal Cord. 2018 Sep;56(9):863-872. doi: 10.1038/s41393-018-0089-8. Epub 2018 Mar 20.
PubMed 29559683
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05997251
- Acronym / sponsor ID
- E2-21-89
- Conditions
- Spinal Cord Injuries
- Keywords
- Adiponectin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 18 Aug 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 aim of this study is to reveal the relationship of DASH and Mediterranean diet score with anthropometric measurements and serum adiponectin level in individuals with spinal cord injury. This research was planned as a cross-sectional, case-control study. With the data to be obtained from the research, information will be obtained about the hormonal or biochemical basis of metabolic disorders such as atherosclerosis and insulin resistance that may occur in individuals with spinal cord injury in the long term.
20 individuals with Spinal Cord Injury will be included in the study, and the results of the patients will be compared with 20 healthy individuals. In order to determine the food consumption status of the patients, a 1-day food consumption record will be requested. DASH diet score and Mediterranean diet score will be calculated from dietary records. After 8 hours of fasting, 3 ml of peripheral blood will be taken for the measurement of adiponectin between 08:00 and 09:00 in the morning from the individuals in the study and control groups. Adiponectin level will be measured and its correlation with DASH diet score and Mediterranean diet score will be examined.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with spinal cord injury | – | Other: Keeping a 1-day food consumption record by the patient, Other: Measurement of adiponectin level |
| Healthy group | – | Other: Keeping a 1-day food consumption record by the patient, Other: Measurement of adiponectin level |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to hospital Healthy population from patient care givers of hospital staff
Key inclusion criteria (6 listed)
Key exclusion criteria (3 listed)
- Having any disease
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 |
|---|---|---|
| Keeping a 1-day food consumption record by the patientChecking and receiving the 1-day food consumption record recorded by the patient by the researcher | Other | Healthy group, Patients with spinal cord injury |
| Measurement of adiponectin levelAdiponectin level will be measured for each group | Other | Healthy group, Patients with spinal cord injury |
Primary outcome
Adiponectin level
Time frame: Will be measured at inclusion
Adiponectin level will be measured from peripheral blood
DASH diet score
Time frame: Will be measured at inclusion from one day dietary record
Will be measured at inclusion from one day dietary record
Mediterrenian diet score
Time frame: Will be measured at inclusion from one day dietary record
Will be measured at inclusion from one day dietary record
6 secondary outcomes
Whole blood count
Time frame: Will be measured at inclusion
Fasting blood glucose
Time frame: Will be measured at inclusion
Total cholesterol
Time frame: Will be measured at inclusion
LDL
Time frame: Will be measured at inclusion
HDL
Time frame: Will be measured at inclusion
TG
Time frame: Will be measured at inclusion
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 18 Aug 2023.
- Background: PubMed 16213239Wang YH, Huang TS, Liang HW, Su TC, Chen SY, Wang TD. Fasting serum levels of adiponectin, ghrelin, and leptin in men with spinal cord injury. Arch Phys Med Rehabil. 2005 Oct;86(10):1964-8. doi: 10.1016/j.apmr.2005.04.017.
- Background: PubMed 16708117Ekmekci H, Ekmekci OB. The role of adiponectin in atherosclerosis and thrombosis. Clin Appl Thromb Hemost. 2006 Apr;12(2):163-8. doi: 10.1177/107602960601200203.
- Background: PubMed 29559683O'Brien LC, Graham ZA, Chen Q, Lesnefsky EJ, Cardozo C, Gorgey AS. Plasma adiponectin levels are correlated with body composition, metabolic profiles, and mitochondrial markers in individuals with chronic spinal cord injury. Spinal Cord. 2018 Sep;56(9):863-872. doi: 10.1038/s41393-018-0089-8. Epub 2018 Mar 20.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Spinal Cord Injuries, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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 18 Aug 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 Turkey (Türkiye). 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?
Adiponectin level (time frame: Will be measured at inclusion). The study lists 3 primary outcomes in all. 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 NCT05997251, which also lists 3 linked publications.
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 18 Aug 2023.