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NCT01610011 · ClinicalTrials.gov registry record · NA
Acute Glycine Pharmacodynamic Study
A NA study, sponsored by Mclean Hospital.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT01610011: Completed NA study, sponsored by Mclean Hospital.
NCT01610011 is a NA study that has completed, run by Mclean Hospital. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01610011, a NA study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study is to use proton magnetic resonance spectroscopy (MRS) at 4 Tesla to measure brain glycine levels noninvasively at baseline and for 2 hours after a single oral dose of a concentrated glycine-containing beverage, and to compare MRS glycine measurements to glycine blood levels in samples obtained after each MRS spectrum. The investigators hypothesize that they will observe a high correlation between the magnitude increases in brain and plasma glycine levels over this time frame. The investigators also hypothesize that we will observe large intersubject variability in glycine uptake rates into brain and blood. The investigators also hypothesize that subjects with a glycine decarboxylase (GLDC) mutation (triplication) will have lower baseline plasma and brain glycine levels and will experience smaller brain and plasma glycine increases after glycine consumption than controls or family members without the GLDC mutation.
Primary Outcome
Brain and plasma glycine levels are measured with proton magnetic resonance spectroscopy at 4T and analytically, respectively. Because glycine doses were limited to 30 g to avoid nausea and vomiting, some subjects with higher weights were administered lower doses per body weight of glycine (g/kg). Therefore, we corrected MRS data by the actual glycine dose administered (g/kg) to account for dosing differences.
Interventions
- DIETARY_SUPPLEMENT Glycine administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-12 |
| Phase | NA |
What the finished NCT01610011 record still lists
NCT01610011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Glycine administration is the first listed.
NCT01610011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01610011 about?
NCT01610011 is a clinical study titled "Acute Glycine Pharmacodynamic Study". The purpose of this study is to use proton magnetic resonance spectroscopy (MRS) at 4 Tesla to measure brain glycine levels noninvasively at baseline and for 2 hours after a single oral dose of a concentrated glycine-containing beverage, and to compare MRS glycine measurements to glycine blood level...
What is the current status of trial NCT01610011?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2010-07. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01610011?
The interventions under investigation include: Glycine administration (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01610011?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01610011's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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