Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Sponsor

Oregon Health and Science University (Other)

Overall Status

Completed

CT.gov ID

NCT00843791

Collaborator

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

Enrollment

Location

Arms

26.9

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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	Phase
Obesity Insulin Resistance	Drug: placebo Drug: pioglitazone	N/A

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

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 :

Feb 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

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 Names: thiazolidinedione therapy

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 Names:

thiazolidinedione therapy

Outcome Measures

Primary Outcome Measures

Total and active ghrelin levels [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.

Secondary Outcome Measures

Ghrelin level suppressibility during insulin clamp [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan Purnell, Prinicipal Investigator, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT00843791

Other Study ID Numbers:

eIRB 3941
OCTRI #10647
R01DK071161

First Posted:

Feb 13, 2009

Last Update Posted:

Aug 7, 2019

Last Verified:

Aug 1, 2019

Keywords provided by Jonathan Purnell, Prinicipal Investigator, Oregon Health and Science University

obesity

Additional relevant MeSH terms:

Insulin Resistance

Pioglitazone

2,4-thiazolidinedione

Study Results

No Results Posted as of Aug 7, 2019