Ghrelin Dose Finding In Frail Elderly
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|ClinicalTrials.gov Identifier: NCT01605435|
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : January 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|The Frailty Syndrome||Drug: Ghrelin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Ghrelin In Frail Elderly Subcutaneous Dose Finding Study|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Dose finding with each participant receiving placebo and three doses of ghrelin, separated by 3-7 days
The first three participants will receive 2 mcg/kg as a single subcutaneous dose at Visit 3, 5 mcg/kg as a single subcutaneous dose at Visit 4, and 10 mcg/Kg as a single subcutaneous dose at visit 5. There will be 3-10 days between visits. The next three participants will receive either the same dosing at the first three, a regimen that includes an intermediate dose (e.g., 7.5 mcg/kg), or higher (e.g., 12, 15, and 18 mcg/kg) doses.
- Safety [ Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes ]laboratory measurements compared to placebo (pre- and post-prandial glucose, insulin, free fatty acids, and cortisol).
- Safety [ Time Frame: 0, 15, 30, 45, 60, 90, 120 minutes, 1 day later and through 30 days following the last administration of study treatment. ]Treatment emergent adverse events
- Efficacy [ Time Frame: 2 hours, 30 minutes post injection ]A standardized nutritionally balanced meal provided 30 minutes post injection ) and assessed for caloric intake two hours later based upon returned uneaten portion.
- Growth hormone, total ghrelin and active ghrelin profiles [ Time Frame: 0, 15, 30, 45, 60, 90 and 120 minutes ]
- Food Intake [ Time Frame: Day-1 and Day-2 ]Assessed via self reported food intake record on day 1 and day 2 post injection.
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): NCT01605435
|United States, Pennsylvania|
|Clinical and Translational Research Center, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Anne R. Cappola, M.D., Sc.M.||University Of Pennsylvania, Perelman School of Medicine, Department of Endocrinology, Diabetes and Metabolism|