SarcopeniaSARC-OLDNCT05961878
Diet in Elderly With Type 2 Diabetes
A study testing mediterranean diet with adequate protein intake in people with Sarcopenia and Sarcopenic Obesity, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which may affect performance. Diabetes can affect muscle cell function, making sarcopenia worse. This is a prospective and interventional study on a elderly population affected by type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Sarcopenia, Sarcopenic Obesity, Diabetes Mellitus
- What is being tested?
- mediterranean diet with adequate protein intake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2023to 1 Jul 2025
- 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Type 2 Diabetes
- BMI >20 kg/m2
- HbA1c ≥6.5% (48 mmol/mol) e ≤10% (86 mmol/mol)
Who cannot join
- T1DM or LADA
- Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: Efficacy of Diet in Elderly With Type 2 Diabetes
Sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which may affect performance. Diabetes can affect muscle cell function, making sarcopenia worse.
This is a prospective and interventional study on a elderly population affected by type 2 diabetes mellitus. All subjects, recruited will undergo tests for the diagnosis of sarcopenia according to the EWGSOP2 criteria. All subjects, both sarcopenic and non-sarcopenic, will be introduced to a targeted nutritional program aimed at improving the composition of the diet, in terms of both micro- and macro-nutrients.
Read the detailed description
The sample will consist of about 100 subjects (50 sarcopenic and 50 non-sarcopenic) who receive the nutritional program. Particular attention will be paid to the intake of an adequate protein intake for the elderly subject (1.1 g/kg/day). A food diary will be required to assess daily protein-calorie intake and questionnaires to assess daily physical activity and quality of life.
The primary objective is to assess the efficacy of nutritional intervention in elderly affected by type 2 diabetes mellitus and sarcopenia. The secondary objective is to identify the prevalence of sarcopenia in patients with type 2 diabetes mellitus compared to non-diabetic subjects and to verify the relationship between pharmacological therapy and the presence of sarcopenia as well as evaluate any changes in style and quality of life and of glycometabolic compensation.
- Conditions
- Sarcopenia, Sarcopenic Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Complications
- Being tested
- mediterranean diet with adequate protein intake
- Medical subject headings
- Sarcopenia, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mediterranean diet with adequate protein intakeDietary supplement
balanced mediterranean diet with 1.1 g/kg die protein intake
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenic | Experimental | subjects with sarcopenia diagnosis Receives: Dietary Supplement: mediterranean diet with adequate protein intake |
| Non sarcopenic | Placebo comparator | subjects without sarcopenia diagnosis Receives: Dietary Supplement: mediterranean diet with adequate protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip test
Increase of hand grip strength (units: kg)
Measured: 1 years
Secondary outcomes (3)
Glycemic control
HbA1c (units: mmol/mol)
Measured: 1 year
Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS
fat mass and free fat mass (units: % of total mass)
Measured: 1 year
Dietary lifestyle
variations in intake of simple sugars, animal protein rich foods, saturated fats and cholesterol, UDM: grams/die. All the informations will be collected using 5days food diaries, completed by the patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start31 Jul 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuela Orsi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961878
- Sponsor's protocol ID
- Sarcopenia-diabetes
- Acronym
- SARC-OLD
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diet in Elderly With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05961878
- Acronym / sponsor ID
- SARC-OLD / Sarcopenia-diabetes
- Conditions
- Sarcopenia, Sarcopenic Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 31 Jul 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 27 Jul 2023 (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.
Sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which may affect performance. Diabetes can affect muscle cell function, making sarcopenia worse.
This is a prospective and interventional study on a elderly population affected by type 2 diabetes mellitus. All subjects, recruited will undergo tests for the diagnosis of sarcopenia according to the EWGSOP2 criteria. All subjects, both sarcopenic and non-sarcopenic, will be introduced to a targeted nutritional program aimed at improving the composition of the diet, in terms of both micro- and macro-nutrients.
Detailed description
The sample will consist of about 100 subjects (50 sarcopenic and 50 non-sarcopenic) who receive the nutritional program. Particular attention will be paid to the intake of an adequate protein intake for the elderly subject (1.1 g/kg/day). A food diary will be required to assess daily protein-calorie intake and questionnaires to assess daily physical activity and quality of life.
The primary objective is to assess the efficacy of nutritional intervention in elderly affected by type 2 diabetes mellitus and sarcopenia. The secondary objective is to identify the prevalence of sarcopenia in patients with type 2 diabetes mellitus compared to non-diabetic subjects and to verify the relationship between pharmacological therapy and the presence of sarcopenia as well as evaluate any changes in style and quality of life and of glycometabolic compensation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic | Experimental | Dietary Supplement: mediterranean diet with adequate protein intakesubjects with sarcopenia diagnosis |
| Non sarcopenic | Placebo comparator | Dietary Supplement: mediterranean diet with adequate protein intakesubjects without sarcopenia diagnosis |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Type 2 Diabetes
- BMI >20 kg/m2
- HbA1c ≥6.5% (48 mmol/mol) e ≤10% (86 mmol/mol)
Key exclusion criteria (2 listed)
- T1DM or LADA
- Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system
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 |
|---|---|---|
| mediterranean diet with adequate protein intakebalanced mediterranean diet with 1.1 g/kg die protein intake | Dietary supplement | Non sarcopenic, Sarcopenic |
Primary outcome
Handgrip test
Time frame: 1 years
Increase of hand grip strength (units: kg)
3 secondary outcomes
Glycemic control
Time frame: 1 year
Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS
Time frame: 1 year
Dietary lifestyle
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mediterranean diet with adequate protein intake in people with Sarcopenia and Sarcopenic Obesity, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessia Gaglio, biologist (00393408724498, alessia.gaglio91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip test (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023; AzTrials last refreshed its copy on 29 Oct 2026.