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| ID | Type | Description | Link |
|---|---|---|---|
| OCTRI #10647 | Other Identifier | OCTRI | |
| R01DK071161 | U.S. NIH Grant/Contract | View source |
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Insufficient funds to continue.
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling. |
|
| pioglitizone | Active Comparator | Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | treatment with placebo for 3 months |
| |
| pioglitazone |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 and 3 months |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Q. Purnell, M.D. | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study was terminated early due to lack of funds.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling. placebo: treatment with placebo for 3 months |
| BG001 | Pioglitizone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This aim was terminated early due to a shortage of funds and no samples were analyzed. There is no data to report | Posted | 0 and 3 months |
|
Approximately 3 months per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling. |
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Early termination due to fund shortage that led to small numbers of subjects enrolled and no measurements of primary outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Q Purnell | OREGON HEALTH & SCIENCE UNIVERSITY | 5034941056 | purnellj@ohsu.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months |
|
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Pioglitazone | Treatment with pioglitazone for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |