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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 PreDiabetes, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01951729: Completed Phase 1 study of PreDiabetes, sponsored by Washington University School of Medicine.
NCT01951729 is a Phase 1 study of PreDiabetes that has completed, run by Washington University School of Medicine. The registered enrollment target is 15 participants, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01951729, a Phase 1 study of PreDiabetes, 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 |
What the finished NCT01951729 record still lists
NCT01951729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (98% lower).
The record links to 1 condition, with PreDiabetes appearing as the primary indexed condition, and to 5 interventions - of which Control is the first listed.
NCT01951729 reports a single indexed study location in 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: PreDiabetes.
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.
Learn More About Clinical Trials
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Where NCT01951729's enrollment target sits among peer trials
15 141st of 149 higher than 4 of 149 other PreDiabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PreDiabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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