NCT05961878

Diet in Elderly With Type 2 Diabetes

Efficacy of Diet in Elderly With Type 2 Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 65 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcopenia
• Sarcopenic Obesity
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Complications

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	mediterranean diet with adequate protein intake	balanced mediterranean diet with 1.1 g/kg die protein intake

Timeline

• Start date: 2023-07-31
• Primary completion: 2024-06-01
• Completion: 2025-07-01
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

1 site across 1 country: Italy