Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonathan Purnell, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00843791
First received: February 12, 2009
Last updated: June 4, 2012
Last verified: June 2012

February 12, 2009
June 4, 2012
February 2009
May 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00843791 on ClinicalTrials.gov Archive Site
  • Secondary outcomes for this aim include the degree of insulin suppressibility as measured by a hyperinsulinemic-euglycemic clamp. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Secondary outcomes for this aim include the degree of insulin suppressibility as measured by a hyperinsulinemic-euglycemic clamp, area-under-the-curve measurements during the 12½ hours of meal testing for ghrelin, glucose,insulin and gut-peptides. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin
Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Obesity
  • Insulin Resistance
  • Drug: placebo
    treatment with placebo for 3 months
    Other Name: placebo
  • Drug: pioglitazone
    treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months
    Other Name: thiazolidinedione therapy
  • Placebo Comparator: Placebo
    Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.
    Intervention: Drug: placebo
  • Active Comparator: 2
    Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.
    Intervention: Drug: pioglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00843791
eIRB 3941, OCTRI #10647, R01DK071161
Yes
Jonathan Purnell, Oregon Health and Science University
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
Oregon Health and Science University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP