Diabetes Mellitus, Type 2
Conditions
Brief summary
The age-related loss of muscle mass and function, sarcopenia, has several deleterious effects, such as a reduction in the quality of life and an increase in the incidence of falls, often leading to hospitalisation. The prevalence of sarcopenia is unclear but is estimated to be between 4.6 and 7.9% and the loss of skeletal muscle mass and function is accelerated in people with type 2 diabetes. With the percentage of older people and the percentage of people with type 2 diabetes predicted to rise in coming years it is crucial to develop therapies to increase muscle mass and function. Alterations in nutrition have also been suggested to be of therapeutic use in sarcopenia. Epidemiological data showed that the consumption of fatty fish is positively associated with muscle function in older population, indicating a potential role for long-chain n-3 polyunsaturated fatty acids (LCn-3 PUFA) in increasing muscle mass and function in older people. The aim of the current study, therefore, is to determine the effects of krill oil supplementation on muscle size and function in adults with muscle weakness and type 2 diabetes.
Interventions
DIETARY_SUPPLEMENTKrill Oil
Krill oil supplements 4g/day
DIETARY_SUPPLEMENTVegetable Oil
vegetable oil supplements 4g/day
Sponsors
Dasman Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind
Intervention model description
Parallel Group Randomised Controlled Trial
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Physician confirmed type 2 diabetes. * Age \>/= 40 years * No changes in anti-diabetic medication in the last 3 months. * Muscle weakness (grip strength \<27kg and females \<16kg)
Exclusion criteria
* BMI of 45 or higher * BP of 160/100mmHg or higher * Cancer or cancer that has been in remission \<5 years * Any medical condition that prevents participants from exercising safely * On anticoagulant therapy * Allergies to seafood * Regular consumption of more than 2 portions of oily fish per week * Currently consuming omega-3 supplements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | Change from baseline to one year | Change in Grip strength |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SPPB | Change from baseline to one year | Change in Short performance physical battery test |
| HbA1c | Change from baseline to one year | Change in glycated haemoglobin |
| Blood pressure | Change from baseline to one year | Change in blood pressure |
| body mass | Change from baseline to one year | Change in body mass |
| Lean mass | Change from baseline to one year | Change in lean mass |
| Body fat | Change from baseline to one year | Change in body fat |
| BMC | Change from baseline to one year | Change in bone mineral content |
| BMD | Change from baseline to one year | Change in bone mineral density |
| Erythrocyte fatty acid profile | Change from baseline to one year | Change in Erythrocyte fatty acid profile |
Countries
Kuwait
Contacts
Primary ContactStuart R Gray
Outcome results
None listed