Metabolic Syndrome X, Sarcopenia, Type 2 Diabetes Mellitus
Conditions
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTEPAX 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
DIETARY_SUPPLEMENTMaize (corn) oil
6 x 1g capsules per day for 9 months
Sponsors
University of Aberdeen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp | 0 months and 9 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in plasma inflammatory markers | 0, 4 and 9 months |
Countries
United Kingdom
Outcome results
None listed