Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

January 5, 2023 updated by: Jonathan Purnell, Oregon Health and Science University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.
Drug: placebo
treatment with placebo for 3 months
Active Comparator: pioglitizone
Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.
Drug: pioglitazone
treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months
Other Names:
  • thiazolidinedione therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total and Active Ghrelin Levels
Time Frame: 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.
0 and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ghrelin level suppressibility during insulin clamp
Time Frame: 3 months
Secondary outcomes for this aim include the degree of insulin suppressibility as measured by a hyperinsulinemic-euglycemic clamp.
3 months
Ghrelin level suppressibility as a function of AUC gut peptides
Time Frame: 3 months
Secondary outcome for this aim include the degree of insulin suppressibility as measured by an area-under-the-curve measurements during the 12½ hours of meal testing for ghrelin, glucose,insulin and gut-peptides.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eIRB 3941
  • OCTRI #10647 (Other Identifier: OCTRI)
  • R01DK071161 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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