An interventional study of unacylated ghrelin and acyl ghrelin in the Diabetic Process, sponsored by David Dalessio. Status unknown at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-14.
Sponsored by David Dalessio · Not applicable and Interventional
Use of human unacylated ghrelin (UAG, also called des-octanoyl ghrelin) to study physiology in healthy subjects. The proposed research is an investigator-initiated study funded by the National Institutes of Health designed to examine the effect of physiologic levels of UAG on the regulation of glucose homeostasis as well as beta cell function.
David Dalessio is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
UAG (4.0 µg/kg/hr)
Drug: unacylated ghrelin
AG (1.0 µg/kg/hr)
Drug: acyl ghrelin
the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr)
Drug: combined acyl and desacyl ghrelin
saline
Drug: saline
IV, UAG (4.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)
IV, AG (1.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)
IV, the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr), one time, for the duration of the study visit (approximately 5 hours)
IV, saline, one time, for the duration of the study visit(approximately 5 hours)
acute insulin release (AIRg)
The primary outcome measure will be AIRg. This is calculated as the incremental insulin release,following IV glucose administration. (For the first ten minutes of the study visit.)
Time frame: one year
Insulin sensitivity
1. Insulin sensitivity is quantified as the insulin sensitivity index (SI) using Bergman's minimal model of glucose kinetics from the glucose and insulin results obtained from a FSIGT.
Time frame: one year
Disposition index
2. The disposition index (DI) is a measure of β-cell function. It accounts for the modulating effect of insulin sensitivity on β-cell responses. It is calculated as the product of the SI and AIRg
Time frame: one year
glucose tolerance
3. Glucose tolerance is measured by glucose disappearance constant. This is calculated as the slope of the natural log of glucose during the study visit, during a set time frame.
Time frame: one year
This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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