Sarcopenia and Diabetes Mellitus

Completed

• Conditions: Sarcopenia
• Interventions: Radiation: WHOLE BODY DXA

• Registration Number: NCT04407819
• Lead Sponsor: Dionyssiotis, Yannis, M.D.

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 Timeline

• Study Start: 2018-03-20
• Primary Completion: 2018-07-31
• Study Completion: 2018-09-22
• Status Verified: 2020-05
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-27
• Last Update Submitted: 2020-05-27
• Study First Posted: 2020-05-29
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diabetes mellitus type 2	WHOLE BODY DXA	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.
CONTROLS	WHOLE BODY DXA	14 community people who visited the endocrinology outpatient hospital clinic for a routine checkup, or with a non-related to diabetes disease.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
fat mass	Up to 12 weeks	percent of fat mass, Total Fat index

Trial Locations

Locations (1)

Foundation for Care of Neurological Illnesses, Greece; 🇬🇷 Athens, Attica, Greece