Type II Diabetes MellitusNCT02091193
Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus
An observational study of Type II Diabetes Mellitus, run by Danbury Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- Krill Oil (Supplement A)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The groups are selected from primary care offices, a diabetes and endocrine office, as well as self-referrals and medical record confirmed cases of Type 2 Diabetes Mellitus.
Who may be able to join
- Clinical diagnosis of Type 2 Diabetes Mellitus
- Stable on glucose lowering agents
Who cannot join
- Age of less than 18
- Currently pregnant or lactating
- Blood coagulation disorder or taking oral anticoagulants other than aspirin
- Seafood allergy
- Presently taking fish oil or krill oil supplements
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Krill Oil (Supplement A), Placebo (Supplement B)
- Keywords
- Krill Oil, Endothelial Function, Type II Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill Oil (Supplement A)Dietary supplement
Also called Prograde, Inc. Krill Oil
Placebo (Supplement B)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo to Krill Oil | Group 2 receives supplement B for four weeks, undergoes a two week washout period, and then receives supplement A for another four weeks. Measurements are taken at baseline, after supplement B completion and after supplement A completion. Participants are informed which supplement was krill oil and which was placebo following completion of this phase of the study. Group 2 participants are given an option to also take an additional 17 weeks of Krill Oil and return for a follow up evaluating the long term use of krill oil. Receives: Dietary Supplement: Krill Oil (Supplement A); Dietary Supplement: Placebo (Supplement B) | |
| Krill Oil to Placebo | Group 1 receives supplement A for four weeks, undergoes a two week washout period, and then receives supplement B for another four weeks. Measurements are taken at baseline, after supplement A completion and after supplement B completion. Participants are informed which supplement was krill oil and which was placebo following completion of this phase of the study. Group 1 participants are given an option to also take an additional 17 weeks of Krill Oil and return for a follow up evaluating the long term use of krill oil. Receives: Dietary Supplement: Krill Oil (Supplement A); Dietary Supplement: Placebo (Supplement B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endothelial Function with Krill Oil Supplementation as Compared with Baseline and Placebo
Measured: Three Months
Secondary outcomes (1)
Change in Lipid Profile (HDL, LDL, Total Cholesterol), Glucose, Hemoglobin A1C with Krill Oil Supplementation Compared with Baseline and Placebo
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danbury Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Prograde Nutrition
- Responsible party
- Principal investigator, Joann Petrini, PhD, MPH, Danbury Hospital
- Investigators
- Ramin Ahmadi, MD, MPH, Principal investigator, Danbury Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091193
- Sponsor's protocol ID
- 12-02-34-334
- Status last verified
- Aug 2016
- First submitted
- 17 Mar 2014
- Last updated
- 10 Aug 2016
- Results posted
- No
Publications
Wijendran V, Huang MC, Diau GY, Boehm G, Nathanielsz PW, Brenna JT. Efficacy of dietary arachidonic acid provided as triglyceride or phospholipid as substrates for brain arachidonic acid accretion in baboon neonates. Pediatr Res. 2002 Mar;51(3):265-72. doi: 10.1203/00006450-200203000-00002.
PubMed 11861929Maki KC, Reeves MS, Farmer M, Griinari M, Berge K, Vik H, Hubacher R, Rains TM. Krill oil supplementation increases plasma concentrations of eicosapentaenoic and docosahexaenoic acids in overweight and obese men and women. Nutr Res. 2009 Sep;29(9):609-15. doi: 10.1016/j.nutres.2009.09.004.
PubMed 19854375Bunea R, El Farrah K, Deutsch L. Evaluation of the effects of Neptune Krill Oil on the clinical course of hyperlipidemia. Altern Med Rev. 2004 Dec;9(4):420-8.
PubMed 15656713Wong CY, Yiu KH, Li SW, Lee S, Tam S, Lau CP, Tse HF. Fish-oil supplement has neutral effects on vascular and metabolic function but improves renal function in patients with Type 2 diabetes mellitus. Diabet Med. 2010 Jan;27(1):54-60. doi: 10.1111/j.1464-5491.2009.02869.x.
PubMed 20121889Lobraico JM, DiLello LC, Butler AD, Cordisco ME, Petrini JR, Ahmadi R. Effects of krill oil on endothelial function and other cardiovascular risk factors in participants with type 2 diabetes, a randomized controlled trial. BMJ Open Diabetes Res Care. 2015 Oct 14;3(1):e000107. doi: 10.1136/bmjdrc-2015-000107. eCollection 2015.
PubMed 26504524
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02091193
- Acronym / sponsor ID
- 12-02-34-334
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Krill Oil, Endothelial Function, Type II Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Danbury HospitalUniversity, hospital or other
- Collaborators
- Prograde Nutrition
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo to Krill Oil | – | Dietary Supplement: Krill Oil (Supplement A), Dietary Supplement: Placebo (Supplement B)Group 2 receives supplement B for four weeks, undergoes a two week washout period, and then receives supplement A for another four weeks. Measurements are taken at baseline, after supplement B completion and after supplement A completion. Participants are informed which supplement was krill oil and which was placebo following completion of this phase of the study. Group 2 participants are given an option to also take an additional 17 weeks of Krill Oil and return for a follow up evaluating the long term use of krill oil. |
| Krill Oil to Placebo | – | Dietary Supplement: Krill Oil (Supplement A), Dietary Supplement: Placebo (Supplement B)Group 1 receives supplement A for four weeks, undergoes a two week washout period, and then receives supplement B for another four weeks. Measurements are taken at baseline, after supplement A completion and after supplement B completion. Participants are informed which supplement was krill oil and which was placebo following completion of this phase of the study. Group 1 participants are given an option to also take an additional 17 weeks of Krill Oil and return for a follow up evaluating the long term use of krill oil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The groups are selected from primary care offices, a diabetes and endocrine office, as well as self-referrals and medical record confirmed cases of Type 2 Diabetes Mellitus.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Type 2 Diabetes Mellitus
- Stable on glucose lowering agents
Key exclusion criteria (5 listed)
- Age of less than 18
- Currently pregnant or lactating
- Blood coagulation disorder or taking oral anticoagulants other than aspirin
- Seafood allergy
- Presently taking fish oil or krill oil supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krill Oil (Supplement A)Also: Prograde, Inc. Krill Oil | Dietary supplement | Krill Oil to Placebo, Placebo to Krill Oil |
| Placebo (Supplement B) | Dietary supplement | Krill Oil to Placebo, Placebo to Krill Oil |
Primary outcome
Change in Endothelial Function with Krill Oil Supplementation as Compared with Baseline and Placebo
Time frame: Three Months
1 secondary outcome
Change in Lipid Profile (HDL, LDL, Total Cholesterol), Glucose, Hemoglobin A1C with Krill Oil Supplementation Compared with Baseline and Placebo
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Background: PubMed 11861929Wijendran V, Huang MC, Diau GY, Boehm G, Nathanielsz PW, Brenna JT. Efficacy of dietary arachidonic acid provided as triglyceride or phospholipid as substrates for brain arachidonic acid accretion in baboon neonates. Pediatr Res. 2002 Mar;51(3):265-72. doi: 10.1203/00006450-200203000-00002.
- Background: PubMed 19854375Maki KC, Reeves MS, Farmer M, Griinari M, Berge K, Vik H, Hubacher R, Rains TM. Krill oil supplementation increases plasma concentrations of eicosapentaenoic and docosahexaenoic acids in overweight and obese men and women. Nutr Res. 2009 Sep;29(9):609-15. doi: 10.1016/j.nutres.2009.09.004.
- Background: PubMed 15656713Bunea R, El Farrah K, Deutsch L. Evaluation of the effects of Neptune Krill Oil on the clinical course of hyperlipidemia. Altern Med Rev. 2004 Dec;9(4):420-8.
- Background: PubMed 20121889Wong CY, Yiu KH, Li SW, Lee S, Tam S, Lau CP, Tse HF. Fish-oil supplement has neutral effects on vascular and metabolic function but improves renal function in patients with Type 2 diabetes mellitus. Diabet Med. 2010 Jan;27(1):54-60. doi: 10.1111/j.1464-5491.2009.02869.x.
- Derived from this study: PubMed 26504524Lobraico JM, DiLello LC, Butler AD, Cordisco ME, Petrini JR, Ahmadi R. Effects of krill oil on endothelial function and other cardiovascular risk factors in participants with type 2 diabetes, a randomized controlled trial. BMJ Open Diabetes Res Care. 2015 Oct 14;3(1):e000107. doi: 10.1136/bmjdrc-2015-000107. eCollection 2015.
- Prograde, Inc Krill Oil InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramin Ahmadi, MD, MPH principal investigator
Danbury Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Diabetes Mellitus, run by Danbury Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Endothelial Function with Krill Oil Supplementation as Compared with Baseline and Placebo (time frame: Three Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091193, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.