Diet in Elderly With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— SARC-OLD  

Official title:

Efficacy of Diet in Elderly With Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05961878
• Other study ID #: Sarcopenia-diabetes
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Alessia Gaglio, biologist
• Phone: 00393408724498
• Email: alessia.gaglio91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• mediterranean diet with adequate protein intake
balanced mediterranean diet with 1.1 g/kg die protein intake

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	health-related quality of life	assesed Sacopenia Quality of life (SarQoL)	1 year
Primary	Handgrip test	Increase of hand grip strength (units: kg)	1 years
Secondary	Glycemic control	HbA1c (units: mmol/mol)	1 year
Secondary	Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS	fat mass and free fat mass (units: % of total mass)	1 year
Secondary	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	1 year