ObesityNCT00843791

Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

A study testing pioglitazone in people with Obesity and Insulin Resistance, run by Oregon Health and Science University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Insulin Resistance
What is being tested?: pioglitazone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Feb 2009to May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

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.

Read the 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.

Conditions: Obesity, Insulin Resistance
Being tested: placebo, pioglitazone
Keywords: obesity
Medical subject headings: Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
treatment with placebo for 3 months
pioglitazoneDrug
Also called thiazolidinedione therapy
treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months

Study groups in NCT00843791
Study group	Role	What they receive
Placebo	Placebo comparator	Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling. Receives: Drug: placebo
pioglitizone	Active comparator	Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy. Receives: Drug: pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

Total and Active Ghrelin Levels
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.
Measured: 0 and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009May 2011

First posted13 Feb 2009 (estimated)
Study startFeb 2009
Primary completionMay 2011
Study completionMay 2011

Why it stopped: Insufficient funds to continue.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00843791
Sponsor's protocol ID: eIRB 3941
Other IDs: OCTRI #10647, R01DK071161
Status last verified: Jan 2023
First submitted: 12 Feb 2009
Last updated: 30 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin
ClinicalTrials.gov ID: NCT00843791
Acronym / sponsor ID: eIRB 3941
Conditions: Obesity, Insulin Resistance
Keywords: obesity
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient funds to continue.
Enrolment: 6 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Feb 2009
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 13 Feb 2009 (estimated)
Results: Posted 30 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placeboTreatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.
pioglitizone	Active comparator	Drug: pioglitazoneTreatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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:

Key exclusion criteria (7 listed)

Actively losing weight
Smokers
Alcohol consumption > 2 drinks/day
Prescription drug use
Recreational drug use

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placebotreatment with placebo for 3 months	Drug	Placebo
pioglitazoneAlso: thiazolidinedione therapytreatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months	Drug	pioglitizone

Primary outcome

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.

Results and safety

Results posted to the registry on 30 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	3	3
Pioglitizone	3	3

Primary outcome: Total and Active Ghrelin Levels

Time frame: 0 and 3 months

Population analysed: This aim was terminated early due to a shortage of funds and no samples were analyzed. There is no data to report

Adverse events

Time frame: Approximately 3 months per participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Pioglitazone	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): Early termination due to fund shortage that led to small numbers of subjects enrolled and no measurements of primary outcome.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
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Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jonathan Q. Purnell, M.D. principal investigator

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing pioglitazone in people with Obesity and Insulin Resistance, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total and Active Ghrelin Levels (time frame: 0 and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00843791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.