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Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

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ClinicalTrials.gov Identifier: NCT00843791
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Insulin Resistance Drug: placebo Drug: pioglitazone

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin
Study Start Date : February 2009
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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: 2
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 Name: thiazolidinedione therapy

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Secondary outcomes for this aim include the degree of insulin suppressibility as measured by a hyperinsulinemic-euglycemic clamp. [ Time Frame: 3 months ]
  2. 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. [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843791

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Jonathan Q. Purnell, M.D. Oregon Health and Science University
More Information

Responsible Party: Jonathan Purnell, Prinicipal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00843791     History of Changes
Other Study ID Numbers: eIRB 3941
OCTRI #10647 ( Other Identifier: OCTRI )
R01DK071161 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by Jonathan Purnell, Oregon Health and Science University:

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs