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

Primary Purpose

Sarcopenia, Sarcopenic Obesity, Diabetes Mellitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
mediterranean diet with adequate protein intake
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sarcopenic

Non sarcopenic

Arm Description

subjects with sarcopenia diagnosis

subjects without sarcopenia diagnosis

Outcomes

Primary Outcome Measures

Handgrip test
Increase of hand grip strength (units: kg)

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2023
Last Updated
July 18, 2023
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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1. Study Identification

Unique Protocol Identification Number
NCT05961878
Brief Title
Diet in Elderly With Type 2 Diabetes
Acronym
SARC-OLD
Official Title
Efficacy of Diet in Elderly With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 31, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Sarcopenic Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sarcopenic
Arm Type
Experimental
Arm Description
subjects with sarcopenia diagnosis
Arm Title
Non sarcopenic
Arm Type
Placebo Comparator
Arm Description
subjects without sarcopenia diagnosis
Intervention Type
Dietary Supplement
Intervention Name(s)
mediterranean diet with adequate protein intake
Intervention Description
balanced mediterranean diet with 1.1 g/kg die protein intake
Primary Outcome Measure Information:
Title
Handgrip test
Description
Increase of hand grip strength (units: kg)
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Glycemic control
Description
HbA1c (units: mmol/mol)
Time Frame
1 year
Title
Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS
Description
fat mass and free fat mass (units: % of total mass)
Time Frame
1 year
Title
Dietary lifestyle
Description
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
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
health-related quality of life
Description
assesed Sacopenia Quality of life (SarQoL)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessia Gaglio, biologist
Phone
00393408724498
Email
alessia.gaglio91@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuela Orsi, MD
Phone
00390255033498
Email
emanuela_orsi@yahoo.it
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Diet in Elderly With Type 2 Diabetes

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