High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of High Protein on Body Composition and Markers of Sarcopenia in Patients With Type 2 Diabetes Mellitus

Conditions
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Type2 Diabetes Mellitus

Intervention / Treatment
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* Other: 1.5 protein
* Other: 0.8 protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must have been diagnosed with type 2 diabetes mellitus during the last 5 years must have BMI 18.5-24.9 Exclusion Criteria: receive dietary supplements extreme dietary habits chronic inflammation disease cancer autoimmune disease

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Dietary intervention with protein intake 1.5 gr/kg/day | Other: 1.5 protein<br>* dietary plan having dietary protein of 1.5 gr/kg/day<br>|
| Experimental: control group<br>Dietary intervention with protein intake 0.8 gr/kg/day | Other: 0.8 protein<br>* dietary plan having dietary protein of 0.8 gr/kg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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older adults, dietary protein, nutrition intervention, sarcopenia, performance, oxidative stress, inflammation, biochemical profile