The Effect of High Protein on Body Composition and Markers of Sarcopenia in Patients With Type 2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- 1.5 protein
- Conditions
- Type2 Diabetes Mellitus
- Sponsor
- National and Kapodistrian University of Athens
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- C reactive protein
- Status
- Completed
- Last Updated
- 9 days ago
Overview
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.
Investigators
Vassilis Paschalis
Professor
National and Kapodistrian University of Athens
Eligibility Criteria
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
- •autoimmune disease
Arms & Interventions
intervention group
Dietary intervention with protein intake 1.5 gr/kg/day
Intervention: 1.5 protein
control group
Dietary intervention with protein intake 0.8 gr/kg/day
Intervention: 0.8 protein
Outcomes
Primary Outcomes
C reactive protein
Time Frame: 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
Time Frame: 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
handgrip strength
Time Frame: Week 0, week 6, week 12
Change from baseline in handgrip strength and will be assessed by handgrip dynamometer
Sit to stand test
Time Frame: Week 0, week 6, week 12
Change from baseline in "Sit to stand" test which measures muscle functionality and will be assessed by chronometer
blood glucose
Time Frame: Week 0, week 6, week 12
Change from baseline in blood glucose and will be assessed by commercially available kit
skeletal muscle mass index
Time Frame: 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
Time Frame: Week 0, week 6, week 12
Change from baseline in calf circumference and will be assessed by measuring tape
Timed up and go test
Time Frame: 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
Time Frame: Week 0, week 6, week 12
Change from baseline in 10 meters walking test which measures muscle functionality and will be assessed by chronometer
Serum insulin
Time Frame: Week 0, week 6, week 12
Change from baseline in serum insulin and will be assessed by commercially available kit
Glycosylated hemoglobin (HbA1)
Time Frame: Week 0, week 6, week 12
Change from baseline in HbA1 and will be assessed by commercially available kit
Secondary Outcomes
- low-density lipoprotein (LDL)(Week 0, week 6, week 12)
- high-density lipoprotein (HDL)(Week 0, week 6, week 12)
- Enzymatic activity of glutathione peroxidase in red blood cell lysate(Week 0, week 6, week 12)
- Enzymatic activity of superoxide dismutase in plasma(Week 0, week 6, week 12)
- triglycerides level(Week 0, week 6, week 12)
- Enzymatic activity of glutathione peroxidase in plasma(Week 0, week 6, week 12)
- cholesterol level(Week 0, week 6, week 12)
- Enzymatic activity of superoxide dismutase in red blood cell lysate(Week 0, week 6, week 12)
- Protein carbonyls in plasma(Week 0, week 6, week 12)