Effects of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males (MK-0000-170)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether 30 mg of pioglitazone administered once daily for up to 28 days to healthy overweight and obese subjects will lead to a significant change in insulin sensitivity, measured in the setting of a hyperinsulinemic euglycemic clamp

Official Title
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A Randomized Clinical Trial to Measure the Effect of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males

Conditions
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Healthy, Overweight, Obesity

Intervention / Treatment
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* Drug: Placebo
* Drug: Comparator: Pioglitazone
* Drug: Comparator: Hyperinsulinemic Euglycemic Clamp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a BMI of greater than 28 kg/m^2 and less than or equal to 38 kg/m^2 Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months Subject is willing to avoid major dietary changes for the duration of the study Exclusion Criteria: Subject has history of diabetes (Type 1, Type 2 or steroid-induced) Subject has a history of hypersensitivity to pioglitazone or other thiazolidinediones Subject has a history of liver disease, other than non-alcoholic fatty liver disease or non-alcoholic steatohepatitis Subject has a history of congestive heart failure Subject has a active or past history of atherosclerotic heart disease, heart failure, osteoporosis, osteopenia, recurrent bone fractures, or anemia Subject has a history of stroke, chronic seizures, or major neurological disorder Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological or renal abnormalities or diseases Subject has a history of neoplastic disease within the past 5 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pioglitazone 30 mg<br>Pioglitazone 30 mg | Drug: Comparator: Pioglitazone<br>* Pioglitazone 30 mg once daily<br>Drug: Comparator: Hyperinsulinemic Euglycemic Clamp<br>* Infusion of Glucose (20% dextrose) to achieve a glucose concentration of 90mg/dL; Infusion of Insulin at a rate of 10 mU/m2/minute from 0 to 180 minutes and at a rate of 40 mU/m2/minute from 180 to 360 minutes; Saline infusion at 60 minutes before the insulin and glucose infusions to keep the antecubital vein open.<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo (to match pioglitazone 30 mg) once daily<br>Drug: Comparator: Hyperinsulinemic Euglycemic Clamp<br>* Infusion of Glucose (20% dextrose) to achieve a glucose concentration of 90mg/dL; Infusion of Insulin at a rate of 10 mU/m2/minute from 0 to 180 minutes and at a rate of 40 mU/m2/minute from 180 to 360 minutes; Saline infusion at 60 minutes before the insulin and glucose infusions to keep the antecubital vein open.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing. |  | Baseline and 28 days | 
| Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing |  | Baseline and 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing. |  | Baseline and 28 days | 
| Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing |  | Baseline and 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers