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| Name | Class |
|---|---|
| Harokopio University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | Dietary intervention with protein intake 1.5 gr/kg/day |
|
| control group | Experimental | Dietary intervention with protein intake 0.8 gr/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.5 protein | Other | dietary plan having dietary protein of 1.5 gr/kg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| skeletal muscle mass index | 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) | Week 0, week 12 |
| calf circumference | Change from baseline in calf circumference and will be assessed by measuring tape | Week 0, week 6, week 12 |
| handgrip strength | Change from baseline in handgrip strength and will be assessed by handgrip dynamometer | Week 0, week 6, week 12 |
| Sit to stand test | Change from baseline in "Sit to stand" test which measures muscle functionality and will be assessed by chronometer | Week 0, week 6, week 12 |
| Timed up and go test | Change from baseline in "Timed up and go" test which measures muscle functionality and will be assessed by chronometer | Week 0, week 6, week 12 |
| 10 meters walking test | Change from baseline in 10 meters walking test which measures muscle functionality and will be assessed by chronometer | Week 0, week 6, week 12 |
| blood glucose | Change from baseline in blood glucose and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| cholesterol level | Change from baseline in cholesterol level and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| triglycerides level | Change from baseline in triglycerides level and will be assessed by commercially available kit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National and Kapodistrian University of Athens | Athens | Attica | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35736019 | Result | Argyropoulou D, Geladas ND, Nomikos T, Paschalis V. Exercise and Nutrition Strategies for Combating Sarcopenia and Type 2 Diabetes Mellitus in Older Adults. J Funct Morphol Kinesiol. 2022 Jun 8;7(2):48. doi: 10.3390/jfmk7020048. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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.
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| 0.8 protein |
| Other |
dietary plan having dietary protein of 0.8 gr/kg/day |
|
| Serum insulin |
Change from baseline in serum insulin and will be assessed by commercially available kit |
| Week 0, week 6, week 12 |
| Glycosylated hemoglobin (HbA1) | Change from baseline in HbA1 and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| C reactive protein | Change from baseline in C reactive protein and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| Dietary intake of macro- and micro-nutrients | Change from baseline in macro- and micro- nutrients and will be assessed with -3 day recall | Week 0, week 3 , week 6, week 9, week 12 |
| Week 0, week 6, week 12 |
| low-density lipoprotein (LDL) | Change from baseline in LDL and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| high-density lipoprotein (HDL) | Change from baseline in HDL and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| Enzymatic activity of glutathione peroxidase in plasma | Change from baseline in enzymatic activity of glutathione peroxidase in plasma and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| Enzymatic activity of glutathione peroxidase in red blood cell lysate | Change from baseline in enzymatic activity of glutathione peroxidase in red blood cell lysate and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| Enzymatic activity of superoxide dismutase in plasma | Change from baseline in superoxide dismutase in plasma and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| Enzymatic activity of superoxide dismutase in red blood cell lysate | Change from baseline in superoxide dismutase in red blood cell lysate and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| Protein carbonyls in plasma | Change from baseline in protein carbonyls in plasma and will be assessed by commercially available kit | Week 0, week 6, week 12 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010335 | Pathologic Processes |