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NCT01681810 · ClinicalTrials.gov registry record · Phase 2
Oral Nitrite in Adults With Metabolic Syndrome and Hypertension
A Phase 2 study, sponsored by Gladwin, Mark, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01681810: Completed Phase 2 study, sponsored by Gladwin, Mark, MD.
NCT01681810 is a Phase 2 study that has completed, run by Gladwin, Mark, MD. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01681810, a Phase 2 study, has completed, sponsored by Gladwin, Mark, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This research study is being conducted to examine the effects of daily inorganic nitrite treatment on the cardiometabolic and hormonal disturbances observed in overweight/obese adults with the metabolic syndrome and high blood pressure. Ultimately, oral nitrite therapy may have a major impact on the prevention and treatment of both diabetes and cardiovascular disease.
Primary Outcome
Change in insulin stimulated glucose disposal was assessed during the 4-hour hyperinsulinemic euglycemic clamp at end of the 12 weeks and was compared to baseline (pre-nitrite). Insulin stimulated glucose disposal (mg/min) was calculated in the final 20 minutes of the 4-hour clamp at steady state and expressed as mg per kg lean body mass (as measured by DEXA) per minute. HumuLIN R regular insulin was infused at a rate of 40 microUnits/m2/min. A non-radioactive glucose isotope dilution (Isotec, I
Interventions
- DRUG 14Nitrogen Sodium Nitrite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-10 |
| Est. Completion | 2018-03-08 |
| Phase | Phase 2 |
What the finished NCT01681810 record still lists
NCT01681810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which 14Nitrogen Sodium Nitrite is the first listed.
NCT01681810 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01681810 about?
NCT01681810 is a clinical study titled "Oral Nitrite in Adults With Metabolic Syndrome and Hypertension". This research study is being conducted to examine the effects of daily inorganic nitrite treatment on the cardiometabolic and hormonal disturbances observed in overweight/obese adults with the metabolic syndrome and high blood pressure. Ultimately, oral nitrite therapy may have a major impact on the...
What is the current status of trial NCT01681810?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2012-10. Estimated completion is 2018-03-08.
What interventions are being tested in trial NCT01681810?
The interventions under investigation include: 14Nitrogen Sodium Nitrite (DRUG).
Who is sponsoring clinical trial NCT01681810?
This trial is sponsored by Gladwin, Mark, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01681810's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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