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临床试验/NCT04407819
NCT04407819已完成不适用

Sarcopenia and Diabetes Mellitus

Dionyssiotis, Yannis, M.D.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
prevalence of sarcopenia in patients with T2D and in the control group

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

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

时间窗: Up to 12 weeks

percents in different groups

Skeletal Muscle Index

时间窗: Up to 12 weeks

Appendicular Muscle Mass/Height2

次要结局

  • fat mass(Up to 12 weeks)

研究者

发起方
Dionyssiotis, Yannis, M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Yannis Dionyssiotis

Post graduate student in Hellenic Open University of Greece

Dionyssiotis, Yannis, M.D.

研究点 (1)

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