Diet in Elderly With Type 2 Diabetes

NCT05961878 | Unknown

• 1 other identifier: Sarcopenia-diabetes
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Handgrip test

  Increase of hand grip strength (units: kg)

  1 years

Secondary Outcomes (3)

• Glycemic control

  1 year

• Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS

  1 year

• Dietary lifestyle

  1 year

Other Outcomes (1)

• health-related quality of life

  1 year

Study Arms (2)

Sarcopenic

EXPERIMENTAL

subjects with sarcopenia diagnosis

Dietary Supplement: mediterranean diet with adequate protein intake

Non sarcopenic

PLACEBO COMPARATOR

subjects without sarcopenia diagnosis

Dietary Supplement: mediterranean diet with adequate protein intake

Interventions

mediterranean diet with adequate protein intake DIETARY_SUPPLEMENT

balanced mediterranean diet with 1.1 g/kg die protein intake

Non sarcopenic; Sarcopenic

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Type 2 Diabetes
• BMI \>20 kg/m2
• HbA1c ≥6.5% (48 mmol/mol) e ≤10% (86 mmol/mol)

You may not qualify if:

• T1DM or LADA
• Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system

Sponsors & Collaborators

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

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Sarcopenia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Alessia Gaglio, biologist

CONTACT

00393408724498; alessia.gaglio91@gmail.com

Emanuela Orsi, MD

CONTACT

00390255033498; emanuela_orsi@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 27, 2023
• Study Start: July 31, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

IT (1)