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NCT02091193 · ClinicalTrials.gov registry record
Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus
A clinical trial, sponsored by Danbury Hospital.
- Completed
- Registry status
- 47
- Enrollment target
NCT02091193 is a clinical trial that has completed, run by Danbury Hospital. The registered enrollment target is 47 participants.
The verdict
NCT02091193 has completed, sponsored by Danbury Hospital.
- COMPLETED
- Registry status
- 47 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effects of krill oil supplementation in patients with Type 2 diabetes mellitus on heart health and laboratory diabetic measurements. Patients who enroll in this study will be asked to visit the Western Connecticut Health Network Biomedical Research Institute on 3 separate occasions: for baseline testing, after 4 weeks of supplementing with krill oil, and after 4 weeks of supplementing with a placebo. Patients will be randomized into one of two groups to determine the order in which they receive the supplement and placebo. Every patient will receive both the krill oil and the placebo, but both the coordinator and the patient are blinded to which is which. At each visit, participants will undergo a non-invasive test which measures the function of the inner lining of blood vessels and they will also have blood drawn. Fasting is required before each appointment. The blood drawn is used to measure their Hemoglobin A1C, Glucose, HDL, LDL, total cholesterol, C-peptide and total antioxidant capacity. Risks to taking krill oil supplements are likely to include bad breath, heartburn, fishy taste, upset stomach, nausea, loose stools, gas, and bloating. Risks of EndoPAT testing are not permanent and may include pain, numbness, tingling, redness, and bruising at the site of the blood pressure cuff. Risks that are associated with drawing blood may include redness, swelling, pain or discomfort, bruising at the site of the needle stick, or in very rare cases, infection at the needle site. To minimize these risks, trained technologists and phlebotomists will be used for all procedures. This is not a treatment option; while involved in this study all participants will continue their regular treatment for Type 2 diabetes mellitus (as well as any other applicable conditions).
Interventions
- DIETARY_SUPPLEMENT Krill Oil (Supplement A)
- DIETARY_SUPPLEMENT Placebo (Supplement B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02091193
The ClinicalTrials.gov registry entry for NCT02091193 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Danbury Hospital, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Krill Oil (Supplement A) is the first listed.
NCT02091193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02091193 about?
NCT02091193 is a clinical study titled "Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus". The purpose of this study is to evaluate the effects of krill oil supplementation in patients with Type 2 diabetes mellitus on heart health and laboratory diabetic measurements. Patients who enroll in this study will be asked to visit the Western Connecticut Health Network Biomedical Research Insti...
What is the current status of trial NCT02091193?
This trial is currently completed. The enrollment target is 47 participants. The study started on 2012-03. Estimated completion is 2013-12.
What interventions are being tested in trial NCT02091193?
The interventions under investigation include: Krill Oil (Supplement A) (DIETARY_SUPPLEMENT), Placebo (Supplement B) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02091193?
This trial is sponsored by Danbury Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.
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