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

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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Other: 1.5 protein; Other: 0.8 protein

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece
      • National and Kapodistrian University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• must have been diagnosed with type 2 diabetes mellitus during the last 5 years
• must have BMI 18.5-34.9

Exclusion Criteria:

• receive dietary supplements
• extreme dietary habits
• chronic inflammation disease
• cancer
• autoimmune disease

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Collaborators: Harokopio University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: older adults; inflammation; sarcopenia; oxidative stress; performance; dietary protein; nutrition intervention; biochemical profile
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Inflammation; Sarcopenia
• Other Study ID Numbers: 1288/03-07-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No