Ghrelin Dose Finding In Frail Elderly
|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.
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|