Viewing Study NCT00352287



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Last Modification Date: 2024-10-26 @ 9:26 AM
Study NCT ID: NCT00352287
Status: COMPLETED
Last Update Posted: 2006-07-14
First Post: 2006-07-12

Brief Title: Study to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight Prediabetic Adults
Sponsor: Stanford University
Organization: Stanford University

Study Overview

Official Title: Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT
Status: COMPLETED
Status Verified Date: 2006-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of the study was to determine the effects of growth hormone and an insulin sensitizer drug in pre-diabetic adults with excessive amounts of abdominal fat Participants received a combination of two drugs 1 recombinant human growth hormone or its placebo and 2 pioglitazone or its placebo We measured the abdominal fat content and blood sugar levels of participants before and after 40 weeks of treatment
Detailed Description: Treatment with recombinant human growth hormone GH has been shown to reduce visceral adipose tissue VAT and improve insulin sensitivity in normoglycemic adults but glucose levels may rise transiently Pioglitazone a thiazolidinedione TZD drug counters the short-term diabetogenic effect of GH in rodents but combined use of these drugs has not been evaluated in humans

The purpose of this study was to determine the effects of GH and a TZD alone and in combination on glucose metabolism visceral adiposity and insulin sensitivity in abdominally obese adults with impaired glucose tolerance The hypothesis that combined treatment attenuates GH-induced increases in glucose concentrations reduces VAT and improves insulin sensitivity over time was tested Sixty-two adults received GH and pioglitazone for 40 weeks in a double-blind randomized placebo-controlled trial

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
1F32-AG02142-1 5F32-AG02142-2 None None None