Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459940
Status:
COMPLETED
Last Update Posted:
2007-04-13
First Post:
2007-04-12
Brief Title:
The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Can Growth Hormones Lipolytic and Insulin-Antagonistic Effects be Modified by Peroxisome Proliferator-Activated Gamma Agonists
Status:
COMPLETED
Status Verified Date:
2007-04
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:
In the present double blind placebo-controlled parallel study we evaluated the impact of 12 weeks thiazolidinedione TZD administration on basal and insulin-stimulated substrate metabolism in growth hormone-replaced adults with growth hormone deficiency
Detailed Description:
In human subjects GH Growth Hormone acutely antagonises the effects of insulin on glucose uptake in skeletal muscle and increases the hepatic glucose production of humans This has clinical implications for patients with active acromegaly in whom the prevalence of glucose intolerance and overt diabetes mellitus is increased It is also of significance in relation to GH replacement therapy in GH-deficient adults not least when considering that a substantial proportion of these patients are insulin resistant in the GH-untreated state There is evidence to indicate that the acute insulin antagonistic effects may be balanced with time by the favourable effects of GH on body composition and physical fitness but the data are ambiguous The mechanism underlying these effects of GH are not fully characterised but there is experimental evidence of a causal linked to the concomitant stimulation of lipolysis since GH-induced insulin resistance is partly abrogated when lipolysis is pharmacologically suppressed This is noteworthy since elevated levels of free fatty acids FFA are also implicated in the pathogenesis of insulin resistance in patients with the metabolic syndrome and type 2 diabetes mellitus Thiazolidinediones TZDs are insulin sensitizers which function as highaffinity agonists for the nuclear peroxisome-proliferator-activated receptor PPAR gamma which improve insulin sensitivity in T2DM PPAR gamma is a nuclear receptor expressed mainly in adipocytes which activates the transcription of genes involved in lipid and glucose metabolism Administration of TZD in T2DM enhances insulin-stimulated glucose uptake via mechanisms including a lowering of circulating FFA and a redistribution of fat away from hepatocytes and myocytes and into peripheral adipocytes To our knowledge the impact of TZDs on GH-induced insulin resistance has not previously been reported Experimental data in human subjects on this issue are of potential importance not only in relation to patients with abnormal GH status but also regarding our understanding of the pathogenesis of insulin resistance in general and the complex actions of PPAR gamma activation in particular
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