Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma
adrenal
1 other identifier
observational
105
1 country
1
Brief Summary
Between September 2006 and September 2008, 35 patients (32 women and 3 men; mean age 49years with adrenal incidentaloma (AI) were prospectively evaluated at the Department of Endocrinology and General Surgery of Istanbul University, Istanbul Medical Faculty. All patients with AI underwent physical examination, including waist circumference. Body mass Index (BMI) was calculated as weight (kg)/ height (m) squared. A BMI \> 30 was considered an index of obesity. A waist circumference \> 88 cm in women and \> 95 cm in men was considered the cutoff for visceral obesity in accordance to the Adult Treatment Panel III (ATP III) metabolic syndrome criteria. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured from the right brachial artery of the patients in a supine position after 10 minutes of rest by using a pneumatic sphygmomanometer by the same doctor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2007
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 7, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedOctober 8, 2008
September 1, 2008
1 year
October 7, 2008
October 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Doppler ultrasonography
at the time of the detection of the adrenal incidentaloma
Study Arms (3)
group 1
patients with adrenal incidentaloma
group 2
Thirty-five subjects comparable for sex, age, and BMI were enrolled as a control group (group 2).
group 3
The other control group (group 3) of 35 healthy individuals matched for sex, age, BMI, metabolic syndrome criteria, cardiovascular risk parameters, menopausal status, smoking status, consumption of alcohol, usage of antihypertensive drugs, insulin or oral hypoglycaemic agents to perform a 1:1 case-control analysis.
Eligibility Criteria
Study parameters at the patients with AI (group 1) were compared with and control subjects. Thirty-five subjects comparable for sex, age, and BMI were enrolled as a control group (group 2). The other control group (group 3) of 35 healthy individuals matched for sex, age, BMI, metabolic syndrome criteria.
You may qualify if:
- Between September 2006 and September 2008, 35 patients (32 women and 3 men; mean age 49.1 ± 12 years) with adrenal incidentaloma (AI) were prospectively evaluated at the Department of Endocrinology and General Surgery of Istanbul University, Istanbul Medical Faculty.
You may not qualify if:
- Patients with known malignancies and clinical or subclinical hormone secreting tumors were also excluded from this study. Patients with abnormalities of cortisol secretion were also excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University
Istanbul, Capa, 34390, Turkey (Türkiye)
Related Publications (2)
Ermetici F, Malavazos AE, Corbetta S, Morricone L, Dall'Asta C, Corsi MM, Ambrosi B. Adipokine levels and cardiovascular risk in patients with adrenal incidentaloma. Metabolism. 2007 May;56(5):686-92. doi: 10.1016/j.metabol.2006.12.018.
PMID: 17445545BACKGROUNDErbil Y, Ozbey N, Barbaros U, Unalp HR, Salmaslioglu A, Ozarmagan S. Cardiovascular risk in patients with nonfunctional adrenal incidentaloma: myth or reality? World J Surg. 2009 Oct;33(10):2099-105. doi: 10.1007/s00268-009-0178-0.
PMID: 19649755DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
yesim erbil, prof
Istanbul University
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 7, 2008
First Posted
October 8, 2008
Study Start
October 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
October 8, 2008
Record last verified: 2008-09