Clinical trial NCT04407819: Sarcopenia and Diabetes Mellitus
Official title: Sarcopenia and Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: sarcopenia
diabetes mellitus
skeletal muscle index
Lead sponsor: Dionyssiotis, Yannis, M.D.
Sponsor class: INDIV
Collaborators: name: University of Thessaly
First posted: 2020-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A group of 36 patients, aged 20-80 years old, 18 male and 17 female with type 2 diabetes mellitus, and a control group with the same demographic characteristics, participated in the study. All were previously examined by an endocrinologist (in a public hospital, private or university outpatient clinic) from March to July 2018. The control group consisted of 14 community people who visited the endocrinology outpatient hospital clinic for a routine checkup, or with a non-related to diabetes disease.

Brief summary: The association of diabetes mellitus type 2 (T2DM) with sarcopenia has not been adequately investigated. Sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which may affect performance.

Detailed description: The relationship between DM and sarcopenia has not been extensively investigated. Skeletal muscle is the primary site of glucose deposition, and decreased muscle mass plays a role in impaired glucose metabolism in patients with insulin resistance and type 2 diabetes. Skeletal muscle resistance to insulin action appears to be the link between type 2 diabetes (T2DM) and sarcopenia. Hyperglycemia is a metabolic dysfunction which can potentially damage muscle cells. Insulin deficiency leads to marked muscle catabolism that can be reversed by exogenous insulin administration.

The metabolic disorder in diabetics may be reversible.Thus, it may be possible to restore physical ability by restoring the musculoskeletal system.Therefore, the diagnosis of sarcopenia if made can lead to interventions which may prevent the deterioration of body composition and the subsequent deterioration of quality of life. According to the results of the aforementioned studies it is still inconclusive if the metabolic disorder in diabetes may be related to sarcopenia, or sarcopenia may be a consequence of diabetes.

Eligibility criteria: Inclusion Criteria:

* T2DM participants were on treatment with oral hypoglycemic agents
* confirmation criteria of a T2DM diagnosis were glycosylated hemoglobin A1c levels ≥ 6.5% and fasting plasma glucose ≥ 126 mg/dl (7 mmol/l).

Exclusion Criteria:

* history of a cerebrovascular event, a heart stent, an artificial cardiac pacemaker or other metallic implant,
* a malignant tumor, liver disease, end stage chronic kidney disease, a thyroid disorder, carpal tunnel syndrome,
* subjects who received special dietary supplements such as protein powder, during the last three months were excluded from the study.

Primary outcomes:
measure: Skeletal Muscle Index
timeFrame: Up to 12 weeks
measure: prevalence of sarcopenia in patients with T2D and in the control group
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: fat mass
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Foundation for Care of Neurological Illnesses, Greece
state: Attica
Study officials:
affiliation: Foundation for Care of Neurological Illnesses, Greece
name: Yannis Dionyssiotis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dionyssiotis Y. Sarcopenia in the Elderly. Eur Endocrinol. 2019 Apr;15(1):13-14. doi: 10.17925/EE.2019.15.1.13. Epub 2019 Apr 12.
citation: Dionyssiotis Y, Kapsokoulou A, Samlidi E, Angoules AG, Papathanasiou J, Chronopoulos E, Kostoglou-Athanassiou I, Trovas G. Sarcopenia: From definition to treatment. Hormones (Athens). 2017 Oct;16(4):429-439. doi: 10.14310/horm.2002.1764. No abstract available.