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NCT01951729 · ClinicalTrials.gov registry record · Phase 1
The Role of Cholinergic Signaling for Mediating the Effects of GIP and/or Xenin-25 on Insulin Secretion
A Phase 1 study of Pre Diabetes, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01951729 is a Phase 1 study of Pre Diabetes that has completed, run by Washington University School of Medicine. The registered enrollment target is 15 participants, below the 729-participant average among 59 other Pre Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01951729, a Phase 1 study of Pre Diabetes, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Glucose-dependent insulinotropic polypeptide (GIP) is a hormone produced in the intestine. It is released immediately after meal ingestion and increases insulin release. This, in turn, helps reduce blood glucose levels. This circuit does not work properly in humans with type 2 diabetes mellitus (T2DM). We have previously shown that a peptide called xenin-25 can amplify the effects of GIP on insulin secretion in humans. However, xenin-25 no longer does this when humans develop T2DM. Thus, it is important to understand how xenin-25 works in humans without T2DM so we know why it does not work in humans with T2DM. Acetylcholine is molecule produced by specific types of nerves. The effects of acetylcholine can be blocked by a drug called atropine. We have previously shown in mice that atropine prevents the ability of xenin-25 to increase the effects of GIP on insulin release. The purpose of this clinical trial is to determine if atropine also blocks the effects of xenin-25 in humans without T2DM. If it does, then impaired acetylcholine signaling may be one of the reasons humans develop T2DM and it could be possible to develop drugs that bypass this defect and increase insulin release in humans with T2DM.
Conditions Studied
Interventions
- DRUG Control
- DRUG Xenin-25 without atropine
- DRUG GIP without atropine
- DRUG Placebo with atropine
- DRUG Xenin-25 with atropine
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-03-13 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01951729
The ClinicalTrials.gov registry entry for NCT01951729 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 729-participant average among 59 other Pre Diabetes trials with a reported enrollment target (98% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pre Diabetes appearing as the primary indexed condition, and to 5 interventions - of which Control is the first listed.
NCT01951729 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT01951729 about?
NCT01951729 is a clinical study titled "The Role of Cholinergic Signaling for Mediating the Effects of GIP and/or Xenin-25 on Insulin Secretion". Glucose-dependent insulinotropic polypeptide (GIP) is a hormone produced in the intestine. It is released immediately after meal ingestion and increases insulin release. This, in turn, helps reduce blood glucose levels. This circuit does not work properly in humans with type 2 diabetes mellitus (T2D...
What is the current status of trial NCT01951729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2013-03-13. Estimated completion is 2015-05.
What conditions does trial NCT01951729 study?
This clinical trial studies the following conditions: Pre Diabetes.
What interventions are being tested in trial NCT01951729?
The interventions under investigation include: Control (DRUG), Xenin-25 without atropine (DRUG), GIP without atropine (DRUG), Placebo with atropine (DRUG), Xenin-25 with atropine (DRUG).
Who is sponsoring clinical trial NCT01951729?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01951729 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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