Sarcopenia and Orthostatic Hypotension

Sarcopenia Clinical Trial

Official title:

The Relationship Between Sarcopenia and Orthostatic Hypotension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03732716
• Other study ID #: 2052
• Status: Recruiting
• Start date: September 10, 2018
• Est. completion date: December 2018

Study information

• Verified date: November 2018
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: Kudret Keskin, MD
• Phone: 0212 3735000
• Email: keskinkudret[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Elderly patients generally have a tendency for having sarcopenia which refers to muscle loss that may be related to many factors. These patients also have a tendency to falls and injuries. Whether elderly sarcopenic patients have abrupt blood pressure drops upon standing remains unknown. Therefore, in this study, we sought to determine the incidence of orthostatic hypotension in sarcopenic elderly patients and compare it with elderly patients with no sarcopenia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Patients 75 years or older

Exclusion Criteria:

• Pace-maker

• End stage renal insufficiency

• End stage malignancy

• Dehydration

• Severe anemia ( Hgb < 8 gr/dl)

• Acute infection

• Marked edema

• Neurodegenerative disease

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Sarcopenia

Intervention

Diagnostic Test:
• blood pressure measurement
Intervention: Each patient's supine and standing blood pressure measurements will be recorded

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Hashimoto Y, Kaji A, Sakai R, Hamaguchi M, Okada H, Ushigome E, Asano M, Yamazaki M, Fukui M. Sarcopenia is associated with blood pressure variability in older patients with type 2 diabetes: A cross-sectional study of the KAMOGAWA-DM cohort study. Geriatr Gerontol Int. 2018 Sep;18(9):1345-1349. doi: 10.1111/ggi.13487. Epub 2018 Jul 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure	All blood pressure measurements will be performed in the morning after an eight-hour fasting. After 5-minute rest, the first blood pressure measurement will be taken when the patients are supine. Later, three more consecutive measurements will be recorded when the patients stand up each being one-minute apart. All measurements will be performed using a fully automated sphygmomanometer that is attached with the correctly sized cuff matching to the patients' upper arm circumference. OH is defined as a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within 3 minutes of standing. The accompanying symptoms such as dizziness, unable to maintain balance, blurred vision will also be recorded.	0-3 minutes