Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Oregon Health and Science University6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Obesity Insulin Resistance

Interventions

placeboDRUG

treatment with placebo for 3 months

pioglitazoneDRUG

treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Total and Active Ghrelin Levels

The primary outcome of this study will be the comparison of ghrelin suppressibility (total and acylated) in response to meals obese subjects before and after 3-months therapy with a thiazolidinedione.

Time frame: 0 and 3 months

Data from ClinicalTrials.gov

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