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Trial Outcomes & Findings for Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin (NCT NCT00843791)

NCT ID: NCT00843791

Last Updated: 2023-01-30

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

0 and 3 months

Results posted on

2023-01-30

Participant Flow

Subjects will be recruited to participate in this aim from the Portland-Vancouver area through postings on the OHSU website, recruitment from previous studies, and advertisements in local newspapers. Original study recruitment dates were 2009 to 2013.

Following consent, patients undergo screening for entry criteria using blood work and an oral glucose tolerance test. Participants are excluded if they did not have impaired glucose tolerance and/or a contraindication to using a thiazolidinedione (pioglitazone or Actos), such as heart failure or abnormal liver studies.

Participant milestones

Participant milestones
Measure
Placebo
Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.
Pioglitizone
Treatment with pioglitazone 30mg daily for two weeks then 45mg every day for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.
Overall Study
STARTED
3
3
Overall Study
COMPLETED
3
3
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=3 Participants
Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling. placebo: treatment with placebo for 3 months
Pioglitizone
n=3 Participants
Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy. pioglitazone: treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months
Total
n=6 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
34 years
STANDARD_DEVIATION 5 • n=5 Participants
40 years
STANDARD_DEVIATION 5.5 • n=7 Participants
37 years
STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
3 participants
n=5 Participants
3 participants
n=7 Participants
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: 0 and 3 months

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

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.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Pioglitazone

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Q Purnell

OREGON HEALTH & SCIENCE UNIVERSITY

Phone: 5034941056

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place