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

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05457088

Collaborator

Harokopio University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes Mellitus	Other: 1.5 protein Other: 0.8 protein	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention group Dietary intervention with protein intake 1.5 gr/kg/day	Other: 1.5 protein dietary plan having dietary protein of 1.5 gr/kg/day
Experimental: control group Dietary intervention with protein intake 0.8 gr/kg/day	Other: 0.8 protein dietary plan having dietary protein of 0.8 gr/kg/day

Arm

Intervention/Treatment

Experimental: intervention group

Dietary intervention with protein intake 1.5 gr/kg/day

Other: 1.5 protein

dietary plan having dietary protein of 1.5 gr/kg/day

Experimental: control group

Dietary intervention with protein intake 0.8 gr/kg/day

Other: 0.8 protein

dietary plan having dietary protein of 0.8 gr/kg/day

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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