NCT00352287|CompletedPhase 4
Study to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight, Prediabetic Adults
Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT
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Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT
Sponsor study identifier
Secondary identifiers
interventional
60
1 country
1
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
July 12, 2006
Actual (reported)July 14, 2006
Actual (reported)Visceral fat content was quantified by CT scan, glucose tolerance was assessed using a 75 gm OGTT and insulin sensitivity was measured using steady-state plasma glucose (SSPG) levels obtained during an insulin suppression test.
Body mass index (BMI), anthropometric measurements, glycohemoglobin and lipid measurements were performed before and after 40 weeks of treatment.
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Recombinant human growth hormone; pioglitazone
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordVeterans Affairs Palo Alto Health Care System
Palo Alto, California, 94304, United States
Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
Andrew R Hoffman, MD
Stanford University
Hamdee Y Attallah, MD
Wayne State University
First Submitted
July 12, 2006
First Posted
July 14, 2006
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
April 2005
Date type not reportedThe Safety and Efficacy of Low and High Carbohydrate Diets
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
July 14, 2006
Record last verified: 2006-07
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Source: ClinicalTrials.gov.
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