Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

treatment with placebo for 3 months

pioglitizone

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

Group Type ACTIVE_COMPARATOR

pioglitazone

Intervention Type DRUG

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

Interventions

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placebo

treatment with placebo for 3 months

Intervention Type DRUG

pioglitazone

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

Intervention Type DRUG

Other Intervention Names

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thiazolidinedione therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes