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

April 19, 2026 updated by: Vassilis Paschalis, National and Kapodistrian University of Athens

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Week 0, week 12
calf circumference
Time Frame: Week 0, week 6, week 12
Change from baseline in calf circumference and will be assessed by measuring tape
Week 0, week 6, week 12
handgrip strength
Time Frame: Week 0, week 6, week 12
Change from baseline in handgrip strength and will be assessed by handgrip dynamometer
Week 0, week 6, week 12
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
Week 0, week 6, week 12
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
Week 0, week 6, week 12
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
Week 0, week 6, week 12
blood glucose
Time Frame: Week 0, week 6, week 12
Change from baseline in blood glucose and will be assessed by commercially available kit
Week 0, week 6, week 12
Serum insulin
Time Frame: Week 0, week 6, week 12
Change from baseline in serum insulin and will be assessed by commercially available kit
Week 0, week 6, week 12
Glycosylated hemoglobin (HbA1)
Time Frame: Week 0, week 6, week 12
Change from baseline in HbA1 and will be assessed by commercially available kit
Week 0, week 6, week 12
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
Week 0, week 6, week 12
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
Week 0, week 3 , week 6, week 9, week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cholesterol level
Time Frame: Week 0, week 6, week 12
Change from baseline in cholesterol level and will be assessed by commercially available kit
Week 0, week 6, week 12
triglycerides level
Time Frame: Week 0, week 6, week 12
Change from baseline in triglycerides level and will be assessed by commercially available kit
Week 0, week 6, week 12
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
Week 0, week 6, week 12
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
Week 0, week 6, week 12
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
Week 0, week 6, week 12
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
Week 0, week 6, week 12
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
Week 0, week 6, week 12
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
Week 0, week 6, week 12
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
Week 0, week 6, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National and Kapodistrian University of Athens

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harokopio University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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