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NCT05169060 · ClinicalTrials.gov registry record · Phase 1
Omega-3 Fatty Acid Lipidomics in Diabetes Peripheral Neuropathy
A Phase 1 study of Diabetic Neuropathies, sponsored by University of Iowa.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT05169060 is a Phase 1 study of Diabetic Neuropathies that is actively recruiting participants, run by University of Iowa. The registered enrollment target is 100 participants, below the 316-participant average among 8 other Diabetic Neuropathies trials with a reported enrollment target (68% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05169060, a Phase 1 study of Diabetic Neuropathies, is actively recruiting participants, sponsored by University of Iowa.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes, affecting about 50% of patients with diabetes and leading to severe morbidity, poor quality of life, high mortality, and high health care costs. Due to the complex structure and anatomy of the peripheral nervous system, DPN presents with a very broad spectrum of clinical symptoms and deficits, including severe pain, sensory deficits, foot ulcers and amputations. Presently there is no treatment for DPN and even with good blood glucose control DPN develops especially in patients with type 2 diabetes. There is a need to identify effective interventions for DPN. Preclinical studies have provided evidence that the combination of fish oil and salsalate is an effective treatment of DPN. The human subject study to be performed will examine the effect of fish oil with and without salsalate on the blood lipid profile and circulating metabolites of omega-3 polyunsaturated fatty acids (PUFA). Fish oil is an excellent source for the nutrition dependent omega-3 PUFA, primarily eicosapentaenoic acid (EPA; 20:5) and docosahexaenoic acid (DHA; 22:6). These fatty acids are the source of anti-inflammatory metabolites known as resolvin, neuroprotectin and maresin. Preclinical studies have also demonstrated that the metabolites of EPA and DHA are neuroprotective. Furthermore, when fish oil is combined with salsalate the production of these metabolites is increased in vivo. Thus, the investigators hypothesize that fish oil and salsalate will be an effective therapy of DPN. However, prior to doing a formal study of the effect of fish oil + salsalate on DPN there is a need to learn more about what concentration combination will provide the most efficacious effect on the omega-3 index (defined as the sum of EPA and DHA, as a percentage of total fatty acids in red blood cells) and that will safely increase the production of the anti-inflammatory metabolites. These studies will be performed at two sites
Conditions Studied
Interventions
- DRUG Fish Oil Concentrate, 1000 Mg Oral Capsule
- DRUG Salsalate Oral Tablet
Study Locations (2)
Iowa
- University of Iowa - Iowa City
Oregon
- Oregon Health Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-06-12 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05169060
The ClinicalTrials.gov registry entry for NCT05169060 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 316-participant average among 8 other Diabetic Neuropathies trials with a reported enrollment target (68% lower). The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Neuropathies appearing as the primary indexed condition, and to 2 interventions - of which Fish Oil Concentrate, 1000 Mg Oral Capsule is the first listed.
NCT05169060 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Iowa, Oregon.
Frequently Asked Questions
What is clinical trial NCT05169060 about?
NCT05169060 is a clinical study titled "Omega-3 Fatty Acid Lipidomics in Diabetes Peripheral Neuropathy". Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes, affecting about 50% of patients with diabetes and leading to severe morbidity, poor quality of life, high mortality, and high health care costs. Due to the complex structure and anatomy of the peripheral nervou...
What is the current status of trial NCT05169060?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2023-06-12. Estimated completion is 2027-07-01.
What conditions does trial NCT05169060 study?
This clinical trial studies the following conditions: Diabetic Neuropathies.
What interventions are being tested in trial NCT05169060?
The interventions under investigation include: Fish Oil Concentrate, 1000 Mg Oral Capsule (DRUG), Salsalate Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05169060?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05169060 being conducted?
This trial has 2 study locations across Iowa, Oregon. 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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