Diet in Elderly With Type 2 Diabetes

Study Overview
=================
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.

Official Title
-----------------
Efficacy of Diet in Elderly With Type 2 Diabetes

Conditions
-----------------
Sarcopenia, Sarcopenic Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Complications

Intervention / Treatment
-----------------
* Dietary Supplement: mediterranean diet with adequate protein intake


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sarcopenic<br>subjects with sarcopenia diagnosis | Dietary Supplement: mediterranean diet with adequate protein intake<br>* balanced mediterranean diet with 1.1 g/kg die protein intake<br>|
| Placebo Comparator: Non sarcopenic<br>subjects without sarcopenia diagnosis | Dietary Supplement: mediterranean diet with adequate protein intake<br>* balanced mediterranean diet with 1.1 g/kg die protein intake<br>|

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 |