Type2 Diabetes Mellitus
Conditions
Keywords
older adults, dietary protein, nutrition intervention, sarcopenia, performance, oxidative stress, inflammation, biochemical profile
Brief summary
This study will investigate the impact of dietary protein intake on progressive muscle loss and functionality (sarcopenia) in older adults with type 2 diabetes mellitus. Sarcopenia is known to have a bidirectional interaction with type 2 diabetes mellitus. Therefore in order to address this bidirectional complication we suggest that an increased intake of dietary protein at 1.5 gr/kg/day (current official recommendation is 0.8 gr/kg/day) could help to treat the sarcopenia, which in turn will help to ameliorate the type 2 diabetes mellitus progression.
Interventions
OTHER1.5 protein
dietary plan having dietary protein of 1.5 gr/kg/day
OTHER0.8 protein
dietary plan having dietary protein of 0.8 gr/kg/day
Sponsors
National and Kapodistrian University of Athens
Harokopio University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
1st group will receive a dietary plan having dietary protein of 1.5gr/kg/day.2nd group will receive a dietary plan having dietary protein of 0.8gr/kg/day.
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* must have been diagnosed with type 2 diabetes mellitus during the last 5 years * must have BMI 18.5-34.9
Exclusion criteria
* receive dietary supplements * extreme dietary habits * chronic inflammation disease * cancer * autoimmune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| skeletal muscle mass index | Week 0, week 12 | Change from baseline in skeletal muscle mass index and will be assessed by dual energy x-ray absorptiometry ((leg lean mass+arm lean mass)/height\^2) |
| calf circumference | Week 0, week 6, week 12 | Change from baseline in calf circumference and will be assessed by measuring tape |
| handgrip strength | Week 0, week 6, week 12 | Change from baseline in handgrip strength and will be assessed by handgrip dynamometer |
| Sit to stand test | Week 0, week 6, week 12 | Change from baseline in "Sit to stand" test which measures muscle functionality and will be assessed by chronometer |
| Timed up and go test | Week 0, week 6, week 12 | Change from baseline in "Timed up and go" test which measures muscle functionality and will be assessed by chronometer |
| 10 meters walking test | Week 0, week 6, week 12 | Change from baseline in 10 meters walking test which measures muscle functionality and will be assessed by chronometer |
| blood glucose | Week 0, week 6, week 12 | Change from baseline in blood glucose and will be assessed by commercially available kit |
| Serum insulin | Week 0, week 6, week 12 | Change from baseline in serum insulin and will be assessed by commercially available kit |
| Glycosylated hemoglobin (HbA1) | Week 0, week 6, week 12 | Change from baseline in HbA1 and will be assessed by commercially available kit |
| C reactive protein | Week 0, week 6, week 12 | Change from baseline in C reactive protein and will be assessed by commercially available kit |
| Dietary intake of macro- and micro-nutrients | Week 0, week 3 , week 6, week 9, week 12 | Change from baseline in macro- and micro- nutrients and will be assessed with -3 day recall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cholesterol level | Week 0, week 6, week 12 | Change from baseline in cholesterol level and will be assessed by commercially available kit |
| triglycerides level | Week 0, week 6, week 12 | Change from baseline in triglycerides level and will be assessed by commercially available kit |
| low-density lipoprotein (LDL) | Week 0, week 6, week 12 | Change from baseline in LDL and will be assessed by commercially available kit |
| high-density lipoprotein (HDL) | Week 0, week 6, week 12 | Change from baseline in HDL and will be assessed by commercially available kit |
| Enzymatic activity of glutathione peroxidase in plasma | Week 0, week 6, week 12 | Change from baseline in enzymatic activity of glutathione peroxidase in plasma and will be assessed by commercially available kit |
| Enzymatic activity of glutathione peroxidase in red blood cell lysate | Week 0, week 6, week 12 | Change from baseline in enzymatic activity of glutathione peroxidase in red blood cell lysate and will be assessed by commercially available kit |
| Enzymatic activity of superoxide dismutase in plasma | Week 0, week 6, week 12 | Change from baseline in superoxide dismutase in plasma and will be assessed by commercially available kit |
| Enzymatic activity of superoxide dismutase in red blood cell lysate | Week 0, week 6, week 12 | Change from baseline in superoxide dismutase in red blood cell lysate and will be assessed by commercially available kit |
| Protein carbonyls in plasma | Week 0, week 6, week 12 | Change from baseline in protein carbonyls in plasma and will be assessed by commercially available kit |
Countries
Greece
Outcome results
None listed