Diet in Elderly With Type 2 Diabetes (SARC-OLD)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Diabetes Complications; Sarcopenic Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Sarcopenia

Treatments: Dietary Supplement: mediterranean diet with adequate protein intake

Study type: Interventional

Funder types: Other

Identifiers

NCT05961878

Sarcopenia-diabetes

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Sarcopenic

Experimental group

Description:

subjects with sarcopenia diagnosis

Treatment:

Dietary Supplement: mediterranean diet with adequate protein intake

Non sarcopenic

Placebo Comparator group

Description:

subjects without sarcopenia diagnosis

Treatment:

Dietary Supplement: mediterranean diet with adequate protein intake