NCT01951716|WithdrawnPhase 1
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Sponsor study identifier
interventional
0
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Glucose-dependent Insulinotropic Polypeptide (GIP) and xenin-25 are peptide hormones produced/released from your intestines and help regulate blood sugar levels after you eat. We have previously performed studies in humans that measured the effects of xenin-25 and GIP (alone and together) on blood sugar levels. One study was conducted with an intravenous infusion of glucose but without ingestion of a meal. In this study, xenin-25 increased the effects of GIP on insulin secretion- but only in humans without type 2 diabetes mellitus (T2DM). A second study was conducted in conjunction with ingestion of a meal. In this study, xenin-25 reduced blood glucose levels by delaying gastric emptying and this effect was similar in humans with and without T2DM. A variety of studies that we have performed suggest that xenin-25 works by activating nerves. A specific nerve called the vagus nerve plays an important role in regulating insulin secretion. This study will determine if the vagus nerve (which was disrupted if you had a vagotomy) is needed for the effects of xenin-25 on insulin secretion and/or gastric emptying.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 23, 2013
Actual (reported)September 27, 2013
Actual (reported)July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Insulin secretion rates will be measured during the GGI and MTTs
3 years
Plasma acetaminophen levels will be measured during MTTs
3 years
Plasma glucose levels will be measured during the GGIs and MTTs.
3 years
Plasma glucagon levels will be measured during the GGIs and MTTs.
3 years
Plasma insulin levels will be measured during the GGIs and MTTs.
3 years
Healthy participants without diabetes who have undergone a complete truncal vagotomy
Healthy participants without diabetes who have not had a complete truncal vagotomy
Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. Starting at 0 minutes, a primed-continuous intravenous infusion of saline containing 1% human albumin will continue for 240 minutes. The study is finished at 240 minutes.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Burton M Wice, PhD
Washington University School of Medicine
Dominic Reeds, MD
Washington University School of Medicine
0 participants (actual enrollment reported by the registry).
First Submitted
September 23, 2013
First Posted
September 27, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. Starting at 0 minutes, a primed-continuous intravenous infusion of GIP in saline containing 1% human albumin will continue for 240 minutes. The study is finished at 240 minutes.
Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. Starting at 0 minutes, a primed-continuous intravenous infusion of xenin-25 in saline containing 1% human albumin will continue for 240 minutes. The study is finished at 240 minutes.
Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. Starting at 0 minutes, a primed-continuous intravenous infusion of GIP plus xenin-25 in saline containing 1% human albumin will continue for 240 minutes. The study is finished at 240 minutes.
At 0 minutes, a liquid mixed meal (Boost Plus) plus acetaminophen will be ingested. Starting at 0 minutes, a primed-continuous intravenous infusion of saline containing 1% human albumin will continue for 300 minutes. The study is finished at 300 minutes.
At 0 minutes, a liquid mixed meal (Boost Plus) plus acetaminophen will be ingested. Starting at 0 minutes, a primed-continuous intravenous infusion of xenin-25 in saline containing 1% human albumin will continue for 300 minutes. The study is finished at 300 minutes.
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Primary Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 26, 2018
Record last verified: 2018-04
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