Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Oregon Health & Science University (OHSU)

Status: Terminated

Conditions: Insulin Resistance; Obesity

Treatments: Drug: pioglitazone; Drug: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00843791

R01DK071161 (U.S. NIH Grant/Contract)

OCTRI #10647 (Other Identifier)

eIRB 3941

Details and patient eligibility

About

The purpose of this study is to learn more about how insulin resistance (inability to process glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.

Full description

Insulin resistance suppresses fasting ghrelin levels and impairs postprandial ghrelin suppression. Improved insulin sensitivity with a thiazolidinedione will raise ghrelin levels, enhance meal-related suppression, but not change the ratio of total to active ghrelin or result in an alteration of ghrelin structure.

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 to 80, weight stable for at least 3 months

• At lifetime maximal body weight and impaired glucose tolerance (ICT) by the World Health ORganization criteria:

  • fasting plasma glucose level of 100- 125mg/dL or
  • plasma glucose level between 140 to 149mg/dL following a 75gram oral glucose load

Exclusion criteria

• Actively losing weight
• Smokers
• Alcohol consumption > 2 drinks/day
• Prescription drug use
• Recreational drug use
• Type 2 Diabetes
• Conditions that contraindicate treatment with pioglitazone such as CHF, impaired liver or kidney function or known sensitivity to pioglitazone

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.

Treatment:

Drug: placebo

pioglitizone

Active Comparator group

Description:

Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.

Treatment:

Drug: pioglitazone