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NCT01977417 · ClinicalTrials.gov registry record · Phase 2
Inflammation Inhibition in Prediabetic Humans
A Phase 2 study, sponsored by Gary L. Pierce.
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT01977417 is a Phase 2 study that was terminated before completion, run by Gary L. Pierce. The registered enrollment target is 21 participants.
The verdict
NCT01977417, a Phase 2 study, was terminated before completion, sponsored by Gary L. Pierce.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
Prediabetes, characterized by elevated fasting blood sugar or exaggerated blood sugar response to sugar ingestion, effects over 79 million adult Americans and is a precursor to the development of Type 2 diabetes. Importantly, approximately 42% of Iowans (950,000) have diabetes and 32% (670,000) have prediabetes with the majority of those with prediabetes going undiagnosed. Adults with prediabetes demonstrate early signs of cardiovascular and nervous system abnormalities and are at high risk for developing overt diabetes unless aggressive lifestyle (weight loss, exercise) or pharmacological interventions are employed. Interestingly, data in recent years has linked obesity and diabetes to chronic inflammation of the blood vessels and brain areas that regulate blood pressure. Therefore, the current study will test whether a commonly used aspirin-like anti-inflammatory drug called salsalate, will improve blood vessel health and nervous system dysfunction in adults with prediabetes. Eligible subjects will have measurements of blood pressure, blood vessel function in the arms and eyes, assessments of nerve activity, and blood samples taken before and after 4 weeks of ingesting an FDA approved aspirin-like drug called salsalate. The study is important because it will identify a potentially new pharmacological strategy to treat vascular and nervous system abnormalities in overweight and obese adults with early stage type 2 diabetes using an inexpensive, generically available drug with an excellent safety record that has been used for decades to treat chronic inflammatory conditions such as rheumatoid arthritis. If proven effective, this will provide preliminary support for the concept of targeting inflammation as a new clinical approach to treating early diabetes related complications. Furthermore, the current pilot study will provide support for developing a larger clinical trial using salsalate that could potentially then be extended to patients with type 2 diabetes and c
Interventions
- DRUG Placebo
- DRUG Salsalate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2012-11 |
| Est. Completion | 2021-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01977417
The ClinicalTrials.gov registry entry for NCT01977417 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gary L. Pierce, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01977417 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01977417 about?
NCT01977417 is a clinical study titled "Inflammation Inhibition in Prediabetic Humans". Prediabetes, characterized by elevated fasting blood sugar or exaggerated blood sugar response to sugar ingestion, effects over 79 million adult Americans and is a precursor to the development of Type 2 diabetes. Importantly, approximately 42% of Iowans (950,000) have diabetes and 32% (670,000) have...
What is the current status of trial NCT01977417?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2012-11. Estimated completion is 2021-04.
What interventions are being tested in trial NCT01977417?
The interventions under investigation include: Placebo (DRUG), Salsalate (DRUG).
Who is sponsoring clinical trial NCT01977417?
This trial is sponsored by Gary L. Pierce, which has 4 total clinical trials registered on ClinicalTrials.gov.
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