Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02091193
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2014-03-17
Brief Title:
Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Sponsor:
Danbury Hospital
Organization:
Danbury Hospital
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None