NCT00768365

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

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

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

October 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
Last Updated

October 8, 2008

Status Verified

September 1, 2008

Enrollment Period

1 year

First QC Date

October 7, 2008

Last Update Submit

October 7, 2008

Conditions

Keywords

adrenal incidentalomacardiovascular risk

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

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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)

Location

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: 17445545BACKGROUND
  • Erbil 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.

MeSH Terms

Conditions

Adrenal Cortex NeoplasmsAdrenal incidentaloma

Condition Hierarchy (Ancestors)

Adrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • yesim erbil, prof

    Istanbul University

    PRINCIPAL INVESTIGATOR

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

Locations