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

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ClinicalTrials.gov Identifier: NCT02426073
Recruitment Status : Unknown
Verified February 2018 by Alfredo Pontecorvi, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : April 24, 2015
Last Update Posted : February 9, 2018
Sponsor:
Collaborators:
University of Rome Tor Vergata
Fondazione Roma
Information provided by (Responsible Party):
Alfredo Pontecorvi, Catholic University of the Sacred Heart

Brief 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.

Condition or disease
Sarcopenia Diabetes Mellitus

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Study Type : Observational
Estimated Enrollment : 76 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Pilot Observational Study to Characterize Glucose Metabolism, Muscle Mass/Function and Inflammatory Profile in Elderly Individuals
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort
HE
Healthy elderlies
DM
Elderlies with type 2 diabetes
SA
Elderlies with sarcopenia
DS
Elderlies with both type 2 diabetes and sarcopenia



Primary Outcome Measures :
  1. Inflammatory markers (TNF-α, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11) [ Time Frame: 2 years ]
    The primary objective of the study is to detect differences in inflammatory markers in the four groups



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Elderly (≥ 70 years) subjects
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426073


Locations
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Italy
Catholic University of Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Andrea Giaccari, MD, PhD    00390630156664    giaccari@rm.unicatt.it   
Sub-Investigator: Andrea Giaccari, MD, PhD         
Principal Investigator: Giovambattista Pani, MD, PhD         
Ospedale San Giovanni Calibita - Fatebenefratelli Isola Tiberina Not yet recruiting
Rome, Italy, 00186
Contact: Simona Frontoni, MD       frontoni@uniroma2.it   
Sponsors and Collaborators
Catholic University of the Sacred Heart
University of Rome Tor Vergata
Fondazione Roma
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Responsible Party: Alfredo Pontecorvi, MD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02426073    
Other Study ID Numbers: 5312/15
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Keywords provided by Alfredo Pontecorvi, Catholic University of the Sacred Heart:
Inflammaging
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms