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

Efficacy of Diet in Elderly With Type 2 Diabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Complications; Sarcopenia; Sarcopenic Obesity
• Intervention / Treatment: Dietary supplement: mediterranean diet with adequate protein intake

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessia Gaglio, biologist; Phone Number: 00393408724498; Email: alessia.gaglio91@gmail.com
• Study Contact Backup: Name: Emanuela Orsi, MD; Phone Number: 00390255033498; Email: emanuela_orsi@yahoo.it

Study Locations

• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sarcopenic; subjects with sarcopenia diagnosis	Dietary supplement: mediterranean diet with adequate protein intake; balanced mediterranean diet with 1.1 g/kg die protein intake
Placebo Comparator: Non sarcopenic; subjects without sarcopenia diagnosis	Dietary supplement: mediterranean diet with adequate protein intake; balanced mediterranean diet with 1.1 g/kg die protein intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip test	Increase of hand grip strength (units: kg)	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	HbA1c (units: mmol/mol)	1 year
Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS	fat mass and free fat mass (units: % of total mass)	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	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
health-related quality of life	assesed Sacopenia Quality of life (SarQoL)	1 year

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Diabetes Mellitus; Diabetes Mellitus, Type 2; Sarcopenia; Diabetes Complications
• Other Study ID Numbers: Sarcopenia-diabetes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No