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Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes
  Purpose

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 Intervention
Obesity
Insulin Resistance
 Drug: placebo
Drug: pioglitazone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: February 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843791

Locations
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)
Investigators
Principal Investigator: Jonathan Q. Purnell, M.D. Oregon Health and Science University
  More Information

No publications provided

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, R01DK071161
Study First Received: February 12, 2009
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
obesity

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Pioglitazone
2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013