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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05997251
Other study ID # E2-21-89
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date March 1, 2022

Study information

Verified date August 2023
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Inclusion criteria (Study group) - 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 Exclusion Criteria: - Exclusion criteria (Study group) - Having an additional disease to the spinal cord injury - Having a 2nd motor neuron lesion Exclusion criteria (Control group) • Having any disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Keeping a 1-day food consumption record by the patient
Checking and receiving the 1-day food consumption record recorded by the patient by the researcher
Measurement of adiponectin level
Adiponectin level will be measured for each group

Locations

Country Name City State
Turkey Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Ekmekci 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. — View Citation

O'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. — View Citation

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. Erratum In: Arch Phys Med Rehabil. 2007 May;88(5):688. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Adiponectin level Adiponectin level will be measured from peripheral blood Will be measured at inclusion
Primary DASH diet score Will be measured at inclusion from one day dietary record Will be measured at inclusion from one day dietary record
Primary Mediterrenian diet score Will be measured at inclusion from one day dietary record Will be measured at inclusion from one day dietary record
Secondary Whole blood count Will be measured at inclusion Will be measured at inclusion
Secondary Fasting blood glucose Will be measured at inclusion Will be measured at inclusion
Secondary Total cholesterol Will be measured at inclusion Will be measured at inclusion
Secondary LDL Will be measured at inclusion Will be measured at inclusion
Secondary HDL Will be measured at inclusion Will be measured at inclusion
Secondary TG Will be measured at inclusion Will be measured at inclusion
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