Diabetes Complications, Diabetes Mellitus, Diabetes Mellitus, Type 2, Sarcopenia, Sarcopenic Obesity
Conditions
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTmediterranean diet with adequate protein intake
balanced mediterranean diet with 1.1 g/kg die protein intake
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes * BMI \>20 kg/m2 * HbA1c ≥6.5% (48 mmol/mol) e ≤10% (86 mmol/mol)
Exclusion criteria
* T1DM or LADA * Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip test | 1 years | Increase of hand grip strength (units: kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 1 year | HbA1c (units: mmol/mol) |
| Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS | 1 year | fat mass and free fat mass (units: % of total mass) |
| Dietary lifestyle | 1 year | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| health-related quality of life | 1 year | assesed Sacopenia Quality of life (SarQoL) |
Countries
Italy
Contacts
Primary ContactAlessia Gaglio, biologist
Backup ContactEmanuela Orsi, MD
Outcome results
None listed