Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001969
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2000-01-18
Brief Title:
Heart Disease Risk Factors in Major Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Factors in Susceptibility to Ischemic Heart Disease in Major Depression Documentation of Insulin Resistance in Patients With Major Depression Utilizing the Hyperinsulinemic Euglycemic Glucose Clamp
Status:
COMPLETED
Status Verified Date:
2007-01-19
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:
None
Brief Summary:
A series of studies in patients with major depression have consistently demonstrated a doubling of the mortality rate at any age independent of suicide In addition the relative risk for clinically significant coronary artery disease in patients with major depression is also 2 or more in studies that independently controlled for risk factors such as smoking hypertension etc The principal long-term goals of the CNE include the determination of the mechanisms that underlie enhanced susceptibility to premature ischemic heart disease in patients with major depression documenting the age at which demonstrable pathophysiologic or predictive changes begin to occur and charting their rate of progression Our long-term goal is to use our understanding of underlying mechanisms to enhance our capacity to predict who with major depression is most likely to develop premature ischemic heart disease to determine what the mechanisms underlying this susceptibility are and to develop improved means for treatment and prevention
Depressed patients are known to manifest a variety of neuroendocrine changes that predispose to coronary artery disease including hypercortisolism decreased secretion of growth hormone and a deficiency of sex steroids A final common denominator of these neuroendocrine abnormalities is insulin resistance Insulin resistance promotes several changes that would favor hypertension and increased coronary artery disease including increased sodium retention increased activity of the sympathetic nervous system proliferation of vascular smooth muscle and deposition of highly metabolically active visceral fat The latter induces additional risk factors for coronary disease including dyslipidemia hypercoagulation and enhanced inflammation It is a matter of public health importance to document the frequency and severity of insulin resistance in patients with major depression compared to a closely matched group of healthy controls To accurately quantify insulin resistance in each patient and control we will apply the hyperinsulinemic euglycemic glucose clamp procedure This is the gold standard method for measuring the insulin sensitivity since it reflects the direct human body glucose metabolic response to a known insulin infusion Moreover it is essential to use this technique in patients with major depression as data indicate that other alternative procedures give unreliable results in the context of hypercortisolism
Depressed patients are known to manifest a variety of neuroendocrine changes that predispose to coronary artery disease including hypercortisolism decreased secretion of growth hormone and a deficiency of sex steroids A final common denominator of these neuroendocrine abnormalities is insulin resistance Insulin resistance promotes several changes that would favor hypertension and increased coronary artery disease including increased sodium retention increased activity of the sympathetic nervous system proliferation of vascular smooth muscle and deposition of highly metabolically active visceral fat The latter induces additional risk factors for coronary disease including dyslipidemia hypercoagulation and enhanced inflammation It is a matter of public health importance to document the frequency and severity of insulin resistance in patients with major depression compared to a closely matched group of healthy controls To accurately quantify insulin resistance in each patient and control we will apply the hyperinsulinemic euglycemic glucose clamp procedure This is the gold standard method for measuring the insulin sensitivity since it reflects the direct human body glucose metabolic response to a known insulin infusion Moreover it is essential to use this technique in patients with major depression as data indicate that other alternative procedures give unreliable results in the context of hypercortisolism
Detailed Description:
A series of studies in patients with major depression have consistently demonstrated a doubling of the mortality rate at any age independent of suicide In addition the relative risk for clinically significant coronary artery disease in patients with major depression is also 2 or more in studies that independently controlled for risk factors such as smoking hypertension etc The principal long-term goals of the CNE include the determination of the mechanisms that underlie enhanced susceptibility to premature ischemic heart disease in patients with major depression documenting the age at which demonstrable pathophysiologic or predictive changes begin to occur and charting their rate of progression Our long-term goal is to use our understanding of underlying mechanisms to enhance our capacity to predict who with major depression is most likely to develop premature ischemic heart disease to determine what the mechanisms underlying this susceptibility are and to develop improved means for treatment and prevention
Depressed patients are known to manifest a variety of neuroendocrine changes that predispose to coronary artery disease including hypercortisolism decreased secretion of growth hormone and a deficiency of sex steroids A final common denominator of these neuroendocrine abnormalities is insulin resistance Insulin resistance promotes several changes that would favor hypertension and increased coronary artery disease including increased sodium retention increased activity of the sympathetic nervous system proliferation of vascular smooth muscle and deposition of highly metabolically active visceral fat The latter induces additional risk factors for coronary disease including dyslipidemia hypercoagulation and enhanced inflammation It is a matter of public health importance to document the frequency and severity of insulin resistance in patients with major depression compared to a closely matched group of healthy controls To accurately quantify insulin resistance in each patient and control we will apply the hyperinsulinemic euglycemic glucose clamp procedure This is the gold standard method for measuring the insulin sensitivity since it reflects the direct human body glucose metabolic response to a known insulin infusion Moreover it is essential to use this technique in patients with major depression as data indicate that other alternative procedures give unreliable results in the context of hypercortisolism
Depressed patients are known to manifest a variety of neuroendocrine changes that predispose to coronary artery disease including hypercortisolism decreased secretion of growth hormone and a deficiency of sex steroids A final common denominator of these neuroendocrine abnormalities is insulin resistance Insulin resistance promotes several changes that would favor hypertension and increased coronary artery disease including increased sodium retention increased activity of the sympathetic nervous system proliferation of vascular smooth muscle and deposition of highly metabolically active visceral fat The latter induces additional risk factors for coronary disease including dyslipidemia hypercoagulation and enhanced inflammation It is a matter of public health importance to document the frequency and severity of insulin resistance in patients with major depression compared to a closely matched group of healthy controls To accurately quantify insulin resistance in each patient and control we will apply the hyperinsulinemic euglycemic glucose clamp procedure This is the gold standard method for measuring the insulin sensitivity since it reflects the direct human body glucose metabolic response to a known insulin infusion Moreover it is essential to use this technique in patients with major depression as data indicate that other alternative procedures give unreliable results in the context of hypercortisolism
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-M-0049 | None | None | None |