Healthy, Overweight, Obesity
Conditions
Keywords
Healthy Volunteers
Brief summary
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
Interventions
DRUGPlacebo
Placebo (to match pioglitazone 30 mg) once daily
Pioglitazone 30 mg once daily
DRUGComparator: 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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed