Sarcopenia and Diabetes Mellitus (SARCoDM)

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Radiation: WHOLE BODY DXA

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11256
      • Foundation for Care of Neurological Illnesses, Greece

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
diabetes mellitus type 2; 36 patients with diabetes mellitus type 2, aged 20-80 years, attending endocrinology outpatient clinics were studied for the assessment of muscle mass and function compared to controls.	Radiation: WHOLE BODY DXA; Muscle mass was estimated by using the whole body DXA (Hologic Horizon W)
CONTROLS; 14 community people who visited the endocrinology outpatient hospital clinic for a routine checkup, or with a non-related to diabetes disease.	Radiation: WHOLE BODY DXA; Muscle mass was estimated by using the whole body DXA (Hologic Horizon W)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal Muscle Index	Appendicular Muscle Mass/Height2	Up to 12 weeks
prevalence of sarcopenia in patients with T2D and in the control group	percents in different groups	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fat mass	percent of fat mass, Total Fat index	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Dionyssiotis, Yannis, M.D.
• Collaborators: University of Thessaly
• Investigators: Principal Investigator: Yannis Dionyssiotis, MD, PhD, Foundation for Care of Neurological Illnesses, Greece

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2018
• Primary Completion (ACTUAL): July 31, 2018
• Study Completion (ACTUAL): September 22, 2018

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (ACTUAL): May 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: sarcopenia; diabetes mellitus; skeletal muscle index
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Diabetes Mellitus; Sarcopenia
• Other Study ID Numbers: EAPDionyssiotis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No