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 : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Insulin Resistance||Drug: placebo Drug: pioglitazone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Placebo Comparator: Placebo
Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.
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.
treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months
Other Name: thiazolidinedione therapy
- 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.
- 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.
- 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.
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|
|Principal Investigator:||Jonathan Q. Purnell, M.D.||Oregon Health and Science University|