Type2 Diabetes MellitusNCT05457088
High Protein Effect on Body Composition and Sarcopenia Markers in Older Patients With Type 2 Diabetes Mellitus
A study testing 1.5 protein and 0.8 protein in people with Type2 Diabetes Mellitus, run by National and Kapodistrian University of Athens at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- 1.5 protein and 0.8 protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGreece
- Study dates
- 1 Nov 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have been diagnosed with type 2 diabetes mellitus during the last 5 years
- must have BMI 18.5-34.9
Who cannot join
- receive dietary supplements
- extreme dietary habits
- chronic inflammation disease
- cancer
- autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- 1.5 protein, 0.8 protein
- Keywords
- older adults, dietary protein, nutrition intervention, sarcopenia, performance, oxidative stress, inflammation, biochemical profile
- Medical subject headings
- Sarcopenia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5 proteinOther
dietary plan having dietary protein of 1.5 gr/kg/day
0.8 proteinOther
dietary plan having dietary protein of 0.8 gr/kg/day
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Dietary intervention with protein intake 1.5 gr/kg/day Receives: Other: 1.5 protein |
| control group | Experimental | Dietary intervention with protein intake 0.8 gr/kg/day Receives: Other: 0.8 protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 0, week 12
calf circumference
Change from baseline in calf circumference and will be assessed by measuring tape
Measured: Week 0, week 6, week 12
handgrip strength
Change from baseline in handgrip strength and will be assessed by handgrip dynamometer
Measured: 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
Measured: 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
Measured: 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
Measured: Week 0, week 6, week 12
blood glucose
Change from baseline in blood glucose and will be assessed by commercially available kit
Measured: Week 0, week 6, week 12
Serum insulin
Change from baseline in serum insulin and will be assessed by commercially available kit
Measured: Week 0, week 6, week 12
Glycosylated hemoglobin (HbA1)
Change from baseline in HbA1 and will be assessed by commercially available kit
Measured: Week 0, week 6, week 12
C reactive protein
Change from baseline in C reactive protein and will be assessed by commercially available kit
Measured: 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
Measured: Week 0, week 3 , week 6, week 9, week 12
Secondary outcomes (9)
cholesterol level
Change from baseline in cholesterol level and will be assessed by commercially available kit
Measured: Week 0, week 6, week 12
triglycerides level
Change from baseline in triglycerides level and will be assessed by commercially available kit
Measured: Week 0, week 6, week 12
low-density lipoprotein (LDL)
Change from baseline in LDL and will be assessed by commercially available kit
Measured: Week 0, week 6, week 12
high-density lipoprotein (HDL)
Change from baseline in HDL and will be assessed by commercially available kit
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 0, week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Nov 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Harokopio University
- Responsible party
- Principal investigator, Vassilis Paschalis, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457088
- Sponsor's protocol ID
- 1288/03-07-2021
- Status last verified
- Apr 2026
- First submitted
- 8 Jul 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 35736019
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Protein on Body Composition and Markers of Sarcopenia in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05457088
- Acronym / sponsor ID
- 1288/03-07-2021
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- older adults, dietary protein, nutrition intervention, sarcopenia, performance, oxidative stress, inflammation, biochemical profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Harokopio University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: 1.5 proteinDietary intervention with protein intake 1.5 gr/kg/day |
| control group | Experimental | Other: 0.8 proteinDietary intervention with protein intake 0.8 gr/kg/day |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must have been diagnosed with type 2 diabetes mellitus during the last 5 years
- must have BMI 18.5-34.9
Key exclusion criteria (5 listed)
- receive dietary supplements
- extreme dietary habits
- chronic inflammation disease
- cancer
- autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.5 proteindietary plan having dietary protein of 1.5 gr/kg/day | Other | intervention group |
| 0.8 proteindietary plan having dietary protein of 0.8 gr/kg/day | Other | control group |
Primary outcome
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)
calf circumference
Time frame: Week 0, week 6, week 12
Change from baseline in calf circumference and will be assessed by measuring tape
handgrip strength
Time frame: Week 0, week 6, week 12
Change from baseline in handgrip strength and will be assessed by handgrip dynamometer
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
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
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
blood glucose
Time frame: Week 0, week 6, week 12
Change from baseline in blood glucose and will be assessed by commercially available kit
Serum insulin
Time frame: Week 0, week 6, week 12
Change from baseline in serum insulin and will be assessed by commercially available kit
Glycosylated hemoglobin (HbA1)
Time frame: Week 0, week 6, week 12
Change from baseline in HbA1 and will be assessed by commercially available kit
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
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
9 secondary outcomes
cholesterol level
Time frame: Week 0, week 6, week 12
triglycerides level
Time frame: Week 0, week 6, week 12
low-density lipoprotein (LDL)
Time frame: Week 0, week 6, week 12
high-density lipoprotein (HDL)
Time frame: Week 0, week 6, week 12
Enzymatic activity of glutathione peroxidase in plasma
Time frame: Week 0, week 6, week 12
Enzymatic activity of glutathione peroxidase in red blood cell lysate
Time frame: Week 0, week 6, week 12
Enzymatic activity of superoxide dismutase in plasma
Time frame: Week 0, week 6, week 12
Enzymatic activity of superoxide dismutase in red blood cell lysate
Time frame: Week 0, week 6, week 12
Protein carbonyls in plasma
Time frame: Week 0, week 6, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Results publication: PubMed 35736019Argyropoulou 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.5 protein and 0.8 protein in people with Type2 Diabetes Mellitus, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skeletal muscle mass index (time frame: Week 0, week 12). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05457088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.