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Clinical Trials/NCT04407819
NCT04407819
Completed
Not Applicable

Sarcopenia and Diabetes Mellitus

Dionyssiotis, Yannis, M.D.1 site in 1 country50 target enrollmentStarted: March 20, 2018Last updated:
ConditionsSarcopenia

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Dionyssiotis, Yannis, M.D.
Enrollment
50
Locations
1
Primary Endpoint
prevalence of sarcopenia in patients with T2D and in the control group

Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

prevalence of sarcopenia in patients with T2D and in the control group

Time Frame: Up to 12 weeks

percents in different groups

Skeletal Muscle Index

Time Frame: Up to 12 weeks

Appendicular Muscle Mass/Height2

Secondary Outcomes

  • fat mass(Up to 12 weeks)

Investigators

Sponsor
Dionyssiotis, Yannis, M.D.
Sponsor Class
Indiv
Responsible Party
Principal Investigator
Principal Investigator

Yannis Dionyssiotis

Post graduate student in Hellenic Open University of Greece

Dionyssiotis, Yannis, M.D.

Study Sites (1)

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