High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus
- Conditions
- Type2 Diabetes Mellitus
- Interventions
- Other: 0.8 proteinOther: 1.5 protein
- Registration Number
- NCT05457088
- Lead Sponsor
- National and Kapodistrian University of Athens
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
- must have been diagnosed with type 2 diabetes mellitus during the last 5 years
- must have BMI 18.5-24.9
- receive dietary supplements
- extreme dietary habits
- chronic inflammation disease
- cancer
- autoimmune disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group 0.8 protein Dietary intervention with protein intake 0.8 gr/kg/day intervention group 1.5 protein Dietary intervention with protein intake 1.5 gr/kg/day
- Primary Outcome Measures
Name Time Method 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
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
blood glucose Week 0, week 6, week 12 Change from baseline in blood glucose and will be assessed by commercially available kit
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
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
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
- Secondary Outcome Measures
Name Time Method 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 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
triglycerides level Week 0, week 6, week 12 Change from baseline in triglycerides level 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
cholesterol level Week 0, week 6, week 12 Change from baseline in cholesterol level 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
Trial Locations
- Locations (1)
National and Kapodistrian University of Athens
🇬🇷Athens, Attiki, Greece