Glucose Metabolism, Muscle Mass/Function and Inflammation in the Elderly

Diabetes Mellitus Clinical Trial

Official title:

Pilot Observational Study to Characterize Glucose Metabolism, Muscle Mass/Function and Inflammatory Profile in Elderly Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426073
• Other study ID #: 5312/15
• Status: Completed
• Start date: January 2017
• Est. completion date: February 2022

Study information

• Verified date: April 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A thorough characterization of glucose metabolism and "inflammaging" in elderly subjects will help determine to what extent each of these factors affects muscle mass/function and contributes to age-related muscle wasting. The investigators will correlate patterns of insulin secretion/sensitivity with "muscle "quality/quantity" in diabetic and non-diabetic elderlies (≥70 years old). By comparing different groups (healthy, sarcopenic, diabetic, diabetic/sarcopenic), the investigators expect to identify an "oxidative/inflammatory signature" (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific for the sarcopenic phenotype and related to muscle insulin resistance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. In all other patients, a diagnosis will be established according to the criteria of the American Diabetes Association

• Sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP)

• Healthy volunteers: no diabetes, no sarcopenia and none of the exclusion criteria

Exclusion Criteria (overall population):

• acute diseases,

• chronic obstructive pulmonary disease (COPD)

• conditions associated with sarcopenia/altered body composition (e.g. disability, altered endocrine function, chronic diseases, nutritional deficiencies, cancer),

• obesity (body mass index =30 kg/m2)

• moderate-severe hepatic disease,

• chronic kidney disease (estimated glomerular filtration rate <30 ml/min per 1.73m2),

• metal prostheses,

• recent or ongoing infection,

• inability or unwillingness to provide informed consent

Exclusion Criteria (diabetic population):

• type 1 diabetes,

• hemoglobin A1c >8.5% (69 mmol/mol),

• basal-bolus insulin therapy,

• insulin pump therapy,

• proliferative diabetic retinopathy,

• diabetic foot.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Sarcopenia

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome
Italy	Ospedale San Giovanni Calibita - Fatebenefratelli Isola Tiberina	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Fondazione Roma, University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers (TNF-a, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11)	The primary objective of the study is to detect differences in inflammatory markers in the four groups	2 years