NCT05997251

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 10, 2023

Last Update Submit

August 10, 2023

Conditions

Keywords

Adiponectin

Outcome Measures

Primary Outcomes (3)

  • Adiponectin level

    Adiponectin level will be measured from peripheral blood

    Will be measured at inclusion

  • DASH diet score

    Will be measured at inclusion from one day dietary record

    Will be measured at inclusion from one day dietary record

  • Mediterrenian diet score

    Will be measured at inclusion from one day dietary record

    Will be measured at inclusion from one day dietary record

Secondary Outcomes (6)

  • Whole blood count

    Will be measured at inclusion

  • Fasting blood glucose

    Will be measured at inclusion

  • Total cholesterol

    Will be measured at inclusion

  • LDL

    Will be measured at inclusion

  • HDL

    Will be measured at inclusion

  • +1 more secondary outcomes

Study Arms (2)

Patients with spinal cord injury

Other: Keeping a 1-day food consumption record by the patientOther: Measurement of adiponectin level

Healthy group

Other: Keeping a 1-day food consumption record by the patientOther: Measurement of adiponectin level

Interventions

Checking and receiving the 1-day food consumption record recorded by the patient by the researcher

Healthy groupPatients with spinal cord injury

Adiponectin level will be measured for each group

Healthy groupPatients with spinal cord injury

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to hospital Healthy population from patient care givers of hospital staff

You may qualify if:

  • Having spent at least 6 months after spinal cord injury
  • st motor neuron injury
  • Being between the ages of 18-65
  • Being between the ages of 18-65
  • Giving consent to participate in the study

You may not qualify if:

  • Having an additional disease to the spinal cord injury
  • Having a 2nd motor neuron lesion
  • Having any disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 16213239BACKGROUND
  • 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.

    PMID: 16708117BACKGROUND
  • 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.

    PMID: 29559683BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations