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

Type2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05457088
• Other study ID #: 1288/03-07-2021
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2022
• Source: National and Kapodistrian University of Athens
• Contact: Vassilis Paschalis, Phd
• Phone: 2107276033
• Email: vpaschalis[@]phed.uoa.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Sarcopenia
• Type2 Diabetes Mellitus

Intervention

Other:
• 1.5 protein
dietary plan having dietary protein of 1.5 gr/kg/day
• 0.8 protein
dietary plan having dietary protein of 0.8 gr/kg/day

Locations

Country	Name	City	State
Greece	National and Kapodistrian University of Athens	Athens	Attiki

Sponsors (2)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	Harokopio University

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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). pii: 48. doi: 10.3390/jfmk7020048. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	calf circumference	Change from baseline in calf circumference and will be assessed by measuring tape	Week 0, week 6, week 12
Primary	handgrip strength	Change from baseline in handgrip strength and will be assessed by handgrip dynamometer	Week 0, week 6, week 12
Primary	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
Primary	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
Primary	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
Primary	blood glucose	Change from baseline in blood glucose and will be assessed by commercially available kit	Week 0, week 6, week 12
Primary	Serum insulin	Change from baseline in serum insulin and will be assessed by commercially available kit	Week 0, week 6, week 12
Primary	Glycosylated hemoglobin (HbA1)	Change from baseline in HbA1 and will be assessed by commercially available kit	Week 0, week 6, week 12
Primary	C reactive protein	Change from baseline in C reactive protein and will be assessed by commercially available kit	Week 0, week 6, week 12
Primary	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	cholesterol level	Change from baseline in cholesterol level and will be assessed by commercially available kit	Week 0, week 6, week 12
Secondary	triglycerides level	Change from baseline in triglycerides level and will be assessed by commercially available kit	Week 0, week 6, week 12
Secondary	low-density lipoprotein (LDL)	Change from baseline in LDL and will be assessed by commercially available kit	Week 0, week 6, week 12
Secondary	high-density lipoprotein (HDL)	Change from baseline in HDL and will be assessed by commercially available kit	Week 0, week 6, week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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