An interventional study of mediterranean diet with adequate protein intake in Sarcopenia, Sarcopenic Obesity and Diabetes Mellitus, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Status unknown at 1 site in Italy. Open to participants aged 65 Years to 95 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Not applicable, Interventional, and Treatment
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.
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.
1,242 studies on the registry are indexed under Sarcopenia; 405 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 793 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 232 studies on the registry; 83 are open to participants now.
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Exclusion Criteria:
subjects with sarcopenia diagnosis
Dietary Supplement: mediterranean diet with adequate protein intake
subjects without sarcopenia diagnosis
Dietary Supplement: mediterranean diet with adequate protein intake
balanced mediterranean diet with 1.1 g/kg die protein intake
Handgrip test
Increase of hand grip strength (units: kg)
Time frame: 1 years
Glycemic control
HbA1c (units: mmol/mol)
Time frame: 1 year
Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS
fat mass and free fat mass (units: % of total mass)
Time frame: 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
Time frame: 1 year
health-related quality of life
assesed Sacopenia Quality of life (SarQoL)
Time frame: 1 year
Start is estimated for Jul 2023; primary completion for Jun 2024, 10 months later.
Of 474 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 10 months is below that.
Counting every sponsor, half of 485 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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