Ignite Creation Date:
2024-05-05 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00768365
Status:
COMPLETED
Last Update Posted:
2008-10-08
First Post:
2008-10-07
Brief Title:
Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
Cardiovascular Risk in Patients With Non-Functional Adrenal Incidentaloma Myth or Reality
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
adrenal
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
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
Detailed Description:
None of the patients with AI showed specific signs andor 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 18 lgdL 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 18 gdL 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 mgdl 3 triglyceride concentrations 150 mgdl 4 HDL cholesterol 40 mgdl in men and 50 mgdl 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 mgdl in men and 50 mgdl in women 4 patients with hypertensive or on antihypertensive medication 5 patients regarded as diabetic 6 current smokers
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 mgdl 3 triglyceride concentrations 150 mgdl 4 HDL cholesterol 40 mgdl in men and 50 mgdl 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 mgdl in men and 50 mgdl in women 4 patients with hypertensive or on antihypertensive medication 5 patients regarded as diabetic 6 current smokers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None