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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-09-30

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

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Detailed Description

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Conditions

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Healthy Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pioglitazone 30 mg

Group Type ACTIVE_COMPARATOR

Comparator: Pioglitazone

Intervention Type DRUG

Pioglitazone 30 mg once daily

Comparator: Hyperinsulinemic Euglycemic Clamp

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (to match pioglitazone 30 mg) once daily

Comparator: Hyperinsulinemic Euglycemic Clamp

Intervention Type DRUG

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.

Interventions

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Placebo

Placebo (to match pioglitazone 30 mg) once daily

Intervention Type DRUG

Comparator: Pioglitazone

Pioglitazone 30 mg once daily

Intervention Type DRUG

Comparator: Hyperinsulinemic Euglycemic Clamp

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes