Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Not Applicable

Terminated

• Conditions: Obesity; Insulin Resistance
• Interventions: Drug: placebo; Drug: pioglitazone

• Registration Number: NCT00843791
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2021-08-04
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-05
• Results First Posted: 2023-01-30
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.
pioglitizone	pioglitazone	Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.

Primary Outcome Measures

Name	Time	Method
Total and Active Ghrelin Levels	0 and 3 months	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.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States