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Completed

NCT Number: NCT04407819

Sarcopenia and Diabetes Mellitus

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WHOLE BODY DXA

Radiation

Muscle mass was estimated by using the whole body DXA (Hologic Horizon W)

Primary outcomes

  1. Skeletal Muscle Index

    Time frame: Up to 12 weeks

    Appendicular Muscle Mass/Height2

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

    Time frame: Up to 12 weeks

    percents in different groups

Secondary outcomes

  1. fat mass

    Time frame: Up to 12 weeks

    percent of fat mass, Total Fat index

Sponsors and collaborators

Lead sponsor

Dionyssiotis, Yannis, M.D.

Indiv

Collaborators

  • University of Thessaly

Registry information

Acronym: SARCoDM

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 29, 2020
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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