Diet in Elderly With Type 2 Diabetes

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus; Sarcopenic Obesity; Diabetes Complications; Sarcopenia; Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: mediterranean diet with adequate protein intake

• Registration Number: NCT05961878
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Study Start: 2023-07-31
• Primary Completion: 2024-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sarcopenic	mediterranean diet with adequate protein intake	subjects with sarcopenia diagnosis
Non sarcopenic	mediterranean diet with adequate protein intake	subjects without sarcopenia diagnosis

Primary Outcome Measures

Name	Time	Method
Handgrip test	1 years	Increase of hand grip strength (units: kg)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy