Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307411
Status:
UNKNOWN
Last Update Posted:
2006-04-04
First Post:
2006-03-27
Brief Title:
Effect of Growth Hormone in Metabolic Syndrome
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Effects of Growth Hormone on Body Fat Distribution Insulin Action and Cardiovascular Risk Factors in Middle-Aged Men With Metabolic Syndrome
Status:
UNKNOWN
Status Verified Date:
2006-03
Last Known Status:
NOT_YET_RECRUITING
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:
Investigating the effect of low dose growth hormone therapy on body fat composition insulin sensitivity and metabolic profiles in middle-aged men with metabolic syndrome and low insulin-like growth factor IGF-1 level
Detailed Description:
Metabolic syndrome a constellation of glucose intolerance hypertension dyslipidemia obesity pro-inflammatory and prothrombotic state culminating to development of premature cardiovascular diseases is a serious public health problem with significant impact on life expectancy societal productivity and quality of life of those afflicted with it Insulin resistance has been proposed as the key linking factor for the metabolic syndrome Although the underlying mechanism for the development of insulin resistance diabetes and metabolic syndrome is not fully understood increasing evidence suggests that neurohormonal dysregulation plays a pivotal role in causing this growing health hazard In our previous study of 307 middle-aged men low insulin-like growth factor IGF-1 level was independently associated with insulin resistance and metabolic syndrome especially amongst those with positive family history of diabetes Replacement with growth hormone has been shown by other researchers to reduce body fat and improve metabolic profiles in patients with adult growth hormone deficiency and type 2 diabetes
We hypothesize that treatment with growth hormone can lead to reduction of body fat insulin resistance and cardiovascular risk factors in men with metabolic syndrome This will be a 12-month prospective randomized double-blind placebo-controlled study using growth hormone treatment in middle-aged men with metabolic syndrome The primary outcome measure will be body fat distribution including changes in visceral and mesenteric fat whereas secondary outcome measure will be insulin sensitivity and tertiary outcome will be variable parameters of metabolic syndrome
The results of this study will have important impact on the treatment of patients with metabolic syndrome and our understanding of the role of growth hormone in the pathogenesis of insulin resistance diabetes and metabolic syndrome
We hypothesize that treatment with growth hormone can lead to reduction of body fat insulin resistance and cardiovascular risk factors in men with metabolic syndrome This will be a 12-month prospective randomized double-blind placebo-controlled study using growth hormone treatment in middle-aged men with metabolic syndrome The primary outcome measure will be body fat distribution including changes in visceral and mesenteric fat whereas secondary outcome measure will be insulin sensitivity and tertiary outcome will be variable parameters of metabolic syndrome
The results of this study will have important impact on the treatment of patients with metabolic syndrome and our understanding of the role of growth hormone in the pathogenesis of insulin resistance diabetes and metabolic syndrome
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