Sarcopenia and Diabetes Mellitus

Sarcopenia Clinical Trial

— SARCoDM  

Official title:

Sarcopenia and Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407819
• Other study ID #: EAPDionyssiotis
• Status: Completed
• Start date: March 20, 2018
• Est. completion date: September 22, 2018

Study information

• Verified date: May 2020
• Source: Dionyssiotis, Yannis, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 22, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Sarcopenia

Intervention

Radiation:
• WHOLE BODY DXA
Muscle mass was estimated by using the whole body DXA (Hologic Horizon W)

Locations

Country	Name	City	State
Greece	Foundation for Care of Neurological Illnesses, Greece	Athens	Attica

Sponsors (2)

Lead Sponsor	Collaborator
Dionyssiotis, Yannis, M.D.	University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal Muscle Index	Appendicular Muscle Mass/Height2	Up to 12 weeks
Primary	prevalence of sarcopenia in patients with T2D and in the control group	percents in different groups	Up to 12 weeks
Secondary	fat mass	percent of fat mass, Total Fat index	Up to 12 weeks