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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 May 2023
• Main ID: NCT02426073
• Date of registration: 21/04/2015
• Prospective Registration: Yes
• Primary sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Public title: Glucose Metabolism, Muscle Mass/Function and Inflammation in the Elderly
• Scientific title: Pilot Observational Study to Characterize Glucose Metabolism, Muscle Mass/Function and Inflammatory Profile in Elderly Individuals
• Date of first enrolment: January 2017
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02426073
• Study type: Observational

Countries of recruitment

Italy

Key inclusion & exclusion criteria

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.



Age minimum: 70 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Sarcopenia

Primary Outcome(s)

Inflammatory markers (TNF-a, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11) [Time Frame: 2 years]

Secondary ID(s)

5312/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fondazione Roma

University of Rome Tor Vergata