Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma (adrenal)
Tracking Information | |||||
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First Received Date ICMJE | October 7, 2008 | ||||
Last Updated Date | October 7, 2008 | ||||
Start Date ICMJE | October 2007 | ||||
Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Doppler ultrasonography [ Time Frame: at the time of the detection of the adrenal incidentaloma ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma | ||||
Official Title ICMJE | Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma: Myth or Reality? | ||||
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. |
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Detailed Description | None of the patients with AI showed specific signs and/or symptoms of hormone excess and none were on hormonal therapy. All patients underwent the following endocrine workup aimed to study the hypothalamic-pituitary-adrenal axis. Serum cortisol, and plasma corticotropin (ACTH) were determined in basal conditions. All patients underwent an overnight 1-mg dexamethasone test. The suppression was adequate when morning cortisol fell below 1.8 lg/dL [21]. If inadequate, a two-day low-dose dexamethasone (DXM) suppression test was performed (2 mg, four times a day for 2 days). Suppressibility was indicated when morning cortisol fell below 1.8 g/dL after the last dose of dexamethasone. In all patients, urinary metanephrine, and normetanephrine excretion were within normal limits and upright plasma aldosterone to plasma renin activity ratio was lower than 20, excluding pheochromocytoma and primary aldosteronism. Metabolic syndrome criteria Metabolic syndrome criteria were determined according to the ATP III and IDF 2005 guideline and modified as follows; (1) a waist circumference > 88 cm in women and > 94 cm in men, (2) fasting glucose concentrations >100 mg/dl, (3) triglyceride concentrations >150 mg/dl, (4) HDL cholesterol <40 mg/dl in men and <50 mg/dl in women, (5) patients with hypertensive or on antihypertensive medication. Presence of waist criteria plus at least two other criteria were accepted as sufficient for the presence of metabolic syndrome. According to the IDF 2005 guideline, population-specific waist circumferences were also used to evaluate abdominal obesity and metabolic syndrome. For this purpose, a waist circumference of > 83 cm for women and > 95 cm for men were regarded as cut-offs for the presence of abdominal obesity. Cardiovascular Risk Parameters Cardiovascular Risk Parameters were as follows according to ATP III; (1) family history of premature ischemic heart disease (ischemic heart disease in male first-degree relatives < 55 years, in female first degree relatives < 65 years (2) for male patients age > 45 years, for female patients age > 55 years or being in menopausal state, (3) HDL cholesterol <40 mg/dl in men and <50 mg/dl in women (4) patients with hypertensive or on antihypertensive medication, (5) patients regarded as diabetic (6) current smokers. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Time Perspective: Prospective | ||||
Biospecimen | |||||
Sampling Method | Non-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. |
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Condition ICMJE | Adrenal Cortex Neoplasms | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 105 | ||||
Completion Date | October 2008 | ||||
Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 20 Years to 70 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Turkey | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00768365 | ||||
Other Study ID Numbers ICMJE | 2007/675 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | yesim erbil, Istanbul University | ||||
Study Sponsor ICMJE | Istanbul University | ||||
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Investigators ICMJE |
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Information Provided By | Istanbul University | ||||
Verification Date | September 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |