Skip to main content
OpenTrials
Completed

NCT Number: NCT05457088

High Protein Effect on Body Composition and Sarcopenia Markers in Older 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type2 Diabetes Mellitus Atrophy Inflammation Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National and Kapodistrian University of Athens

Athens, Attica, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1.5 protein

Other

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

0.8 protein

Other

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

Primary outcomes

  1. skeletal muscle mass index

    Time frame: 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)

  2. calf circumference

    Time frame: Week 0, week 6, week 12

    Change from baseline in calf circumference and will be assessed by measuring tape

  3. handgrip strength

    Time frame: Week 0, week 6, week 12

    Change from baseline in handgrip strength and will be assessed by handgrip dynamometer

  4. Sit to stand test

    Time frame: Week 0, week 6, week 12

    Change from baseline in "Sit to stand" test which measures muscle functionality and will be assessed by chronometer

  5. Timed up and go test

    Time frame: 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

  6. 10 meters walking test

    Time frame: Week 0, week 6, week 12

    Change from baseline in 10 meters walking test which measures muscle functionality and will be assessed by chronometer

  7. blood glucose

    Time frame: Week 0, week 6, week 12

    Change from baseline in blood glucose and will be assessed by commercially available kit

  8. Serum insulin

    Time frame: Week 0, week 6, week 12

    Change from baseline in serum insulin and will be assessed by commercially available kit

  9. Glycosylated hemoglobin (HbA1)

    Time frame: Week 0, week 6, week 12

    Change from baseline in HbA1 and will be assessed by commercially available kit

  10. C reactive protein

    Time frame: Week 0, week 6, week 12

    Change from baseline in C reactive protein and will be assessed by commercially available kit

  11. Dietary intake of macro- and micro-nutrients

    Time frame: 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 outcomes

  1. cholesterol level

    Time frame: Week 0, week 6, week 12

    Change from baseline in cholesterol level and will be assessed by commercially available kit

  2. triglycerides level

    Time frame: Week 0, week 6, week 12

    Change from baseline in triglycerides level and will be assessed by commercially available kit

  3. low-density lipoprotein (LDL)

    Time frame: Week 0, week 6, week 12

    Change from baseline in LDL and will be assessed by commercially available kit

  4. high-density lipoprotein (HDL)

    Time frame: Week 0, week 6, week 12

    Change from baseline in HDL and will be assessed by commercially available kit

  5. Enzymatic activity of glutathione peroxidase in plasma

    Time frame: 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

  6. Enzymatic activity of glutathione peroxidase in red blood cell lysate

    Time frame: 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

  7. Enzymatic activity of superoxide dismutase in plasma

    Time frame: Week 0, week 6, week 12

    Change from baseline in superoxide dismutase in plasma and will be assessed by commercially available kit

  8. Enzymatic activity of superoxide dismutase in red blood cell lysate

    Time frame: 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

  9. Protein carbonyls in plasma

    Time frame: Week 0, week 6, week 12

    Change from baseline in protein carbonyls in plasma and will be assessed by commercially available kit

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Harokopio University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.