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

NCT ID: NCT02426073

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HE

Healthy elderlies

No interventions assigned to this group

DM

Elderlies with type 2 diabetes

No interventions assigned to this group

SA

Elderlies with sarcopenia

No interventions assigned to this group

DS

Elderlies with both type 2 diabetes and sarcopenia

No interventions assigned to this group

Eligibility Criteria

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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)

Exclusion Criteria

* 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


* type 1 diabetes,
* hemoglobin A1c \>8.5% (69 mmol/mol),
* basal-bolus insulin therapy,
* insulin pump therapy,
* proliferative diabetic retinopathy,
* diabetic foot.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role collaborator

Fondazione Roma

UNKNOWN

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Giaccari Andrea

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University of Sacred Heart

Rome, , Italy

Site Status

Ospedale San Giovanni Calibita - Fatebenefratelli Isola Tiberina

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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5312/15

Identifier Type: -

Identifier Source: org_study_id

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