Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma (adrenal)

This study has been completed.
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00768365
First received: October 7, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition
Adrenal Cortex Neoplasms

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma: Myth or Reality?

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Primary Outcome Measures:
  • Doppler ultrasonography [ Time Frame: at the time of the detection of the adrenal incidentaloma ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00768365

Locations
Turkey
Istanbul University
Istanbul, Capa, Turkey, 34390
Sponsors and Collaborators
Istanbul University
Investigators
Principal Investigator: yesim erbil, prof Istanbul University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: yesim erbil, Istanbul University
ClinicalTrials.gov Identifier: NCT00768365     History of Changes
Other Study ID Numbers: 2007/675
Study First Received: October 7, 2008
Last Updated: October 7, 2008
Health Authority: Turkey: Ethics Committee

Keywords provided by Istanbul University:
adrenal incidentaloma
cardiovascular risk

Additional relevant MeSH terms:
Adrenocortical Adenoma
Adrenal Gland Neoplasms
Adrenal Cortex Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014