Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-04 @ 7:51 AM
Study NCT ID:
NCT02091193
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Sponsor:
Danbury Hospital
Organization:
Study Overview
Official Title:
Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: