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

October 7, 2008 updated by: Istanbul University

Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma: Myth or Reality?

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Capa
      • Istanbul, Capa, Turkey, 34390
        • Istanbul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Doppler ultrasonography
Time Frame: at the time of the detection of the adrenal incidentaloma
at the time of the detection of the adrenal incidentaloma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: yesim erbil, prof, Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 7, 2008

First Submitted That Met QC Criteria

October 7, 2008

First Posted (Estimate)

October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

October 8, 2008

Last Update Submitted That Met QC Criteria

October 7, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/675

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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