Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth - NCT00413335-06520 (Clinical Trial 158863)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy158863.aspx
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| City: |
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New Haven |
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State:
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CT |
| Zip Code: |
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06520 |
| Conditions: |
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Obesity - Impaired Glucose Tolerance - Type 2 Diabetes Mellitus |
| Purpose: |
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The purpose of the study is to determine whether treatment of children and adolescents with
Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin
sensitivity and glucose tolerance.
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| Study summary: |
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Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence
in obese children and adolescents with marked obesity. This condition tends to progress to
Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of
childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in
this population set the stage for a series of studies aimed at understanding the metabolic
phenotype and natural history of pre-diabetes in obese youth. We found that obese children
and adolescents with IGT are characterized by marked insulin resistance related to altered
lipid partitioning, favoring lipid deposition in the visceral and intramyocellular
compartment. Furthermore, we found an impairment of the acute insulin response in these
youngsters. Follow-up revealed a rapid deterioration from IGT to frank diabetes. Based on
these studies, there is a strong rationale for changing the balance between visceral and
subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve
insulin sensitivity.
The primary objective of this study is to determine, in a group of ethnically diverse
children and adolescents with IGT, whether treatment with rosiglitazone leads to
improvements in insulin sensitivity and glucose tolerance. Secondary objectives are to
determine whether rosiglitazone is safe and well tolerated. |
| Criteria: |
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Inclusion Criteria:
- Good general health
- Aged 10 to 18 yrs (females: Tanner stage II-V;and males:testes size>6ml)
- IGT based on 2-hr plasma glucose>140mg/dl and <200mg/dl during an OGTT.
Exclusion Criteria:
- Baseline creatinine>1.0mg
- AST and ALT>2.5 ULN
- Anemia (Hct<30)
- Pregnancy (females must have a negative urine pregnancy test during the study)
- Cardiac or pulmonary or other significant chronic illness
- Plans to increase the frequency or intensity of a regular exercise program
- Psychiatric disorder or substance abuse of anorexic agents. |
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| Study is available at: |
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Yale School of Medicine
New Haven, CT 06520
United States
Primary Contact:
Sonia Caprio, MD
Email: sonia.caprio@yale.edu
Phone: 203-785-5692
Secondary Contact:
Sonia Caprio, MD
Email: sonia.caprio@yale.edu
Phone: 203-785-5692 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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