Effect of Fish Oil on Insulin Sensitivity

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Chronic Long-chain n-3 PUFA Supplement and Insulin Action in Human Subjects With Impaired Glucose Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241474
• Other study ID #: UofAberdeen RINH HNU800
• Status: Completed
• Phase: N/A
• First received: November 10, 2010
• Last updated: August 6, 2012
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a prolonged (9 month) high (6g/d) of marine oil improves insulin sensitivity and glucose control in subjects with impaired glucose regulation.

Description:

The incidence of Type 2 diabetes is related both to age and obesity. The disease impacts on quality of life and treatments represent a major health cost. Prevention or delayed onset of the disease remains a key target. Animal studies have shown that provision of high amounts of fish oil in the diet improves insulin sensitivity but human trials have proved equivocal. Recent dose-response trials in animals have shown the improved insulin sensitivity only occurs when the proportion of n-3 long chain polyunsaturated fatty acids (n-3 PUFA), docosahexaenoic acid and eicosapentaenoic acid, exceeds 14% of the total phospholipid fraction within tissue cell membranes. To achieve such values in humans would require a high dose of n-3 PUFA supplied over a prolonged period of time. This is tested within the current study where a daily dose of 6 g day of fish oil (containing a total of 3g docosahexaenoic acid plus eicosapentaenoic acid) is supplied for 9 months. As well as improving control of glycemia increased insulin sensitivity may also enhance protein metabolism and reduce the impact of frailty in older subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 69 Years

Eligibility

Inclusion Criteria:

• Men and post-menopausal women aged 40-65 years

• Recruited from the surrounding community of Aberdeen

• Insulin resistance with either

1. venous plasma fasting glucose > 5.0, < 7.0 mmo/l,

2. venous plasma 2-h 75-g OGTT > 5.0, < 11.1 mmol/l

3. newly diagnosed with type 2 diabetes; must be asymptomatic and detected during our screenings and not require oral hypoglycemic or insulin therapy, HbA1c < 7.0%

Exclusion Criteria:

• Diabetes requiring oral hypoglycemic therapy or insulin

• Treatment with anticoagulants, regular steroids or non-steroidal anti-inflammatory drug treatment, tricyclic antidepressants, anti-arrhythmics

• Hepatic failure

• Renal failure

• Significant respiratory disease

• Anaemia

• Cardiovascular disease

• Malignancy

• Thromboembolic or coagulation disorders

• Alcoholism or other substance misuse

• Eating disorders or significant psychiatric disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Metabolic Syndrome X
• Sarcopenia
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates
6 x 1g capsules per day of marine oil (contains 3g/d docosahexaenoic acid plus eicosapentaenoic acid) for a 9 month period
• Maize (corn) oil
6 x 1g capsules per day for 9 months

Locations

Country	Name	City	State
United Kingdom	Rowett Institute of Nutrition and Health, University of Aberdeen	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp		0 months and 9 months	No
Secondary	Change in amount of docosahexaenoic acid and eicosapentaenoic acid incorporated into phospholipid fraction of red blood cell membranes		at monthly intervals between 0 and 9 months	No
Secondary	Change in plasma inflammatory markers		0, 4 and 9 months	No