Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Obesity Clinical Trial

Official title:

Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00843791
• Other study ID #: eIRB 3941
• Secondary ID: OCTRI #10647R01D
• Status: Terminated
• Phase: N/A
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: January 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Drug:
• placebo
treatment with placebo for 3 months
• pioglitazone
treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 and 3 months