Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2023-07-31
2025-07-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sarcopenic
subjects with sarcopenia diagnosis
mediterranean diet with adequate protein intake
balanced mediterranean diet with 1.1 g/kg die protein intake
Non sarcopenic
subjects without sarcopenia diagnosis
mediterranean diet with adequate protein intake
balanced mediterranean diet with 1.1 g/kg die protein intake
Interventions
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mediterranean diet with adequate protein intake
balanced mediterranean diet with 1.1 g/kg die protein intake
Eligibility Criteria
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Inclusion Criteria
* BMI \>20 kg/m2
* HbA1c ≥6.5% (48 mmol/mol) e ≤10% (86 mmol/mol)
Exclusion Criteria
* Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system
65 Years
95 Years
ALL
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Emanuela Orsi
medical doctor
Locations
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Countries
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Central Contacts
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Other Identifiers
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Sarcopenia-diabetes
Identifier Type: -
Identifier Source: org_study_id
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