NCT04407819

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 19, 2020

Last Update Submit

May 27, 2020

Conditions

Sarcopenia

Keywords

sarcopeniadiabetes mellitusskeletal muscle index

Outcome Measures

Primary Outcomes (2)

  • Skeletal Muscle Index

    Appendicular Muscle Mass/Height2

    Up to 12 weeks

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

    percents in different groups

    Up to 12 weeks

Secondary Outcomes (1)

  • fat mass

    Up to 12 weeks

Study Arms (2)

diabetes mellitus type 2

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.

Radiation: WHOLE BODY DXA

CONTROLS

14 community people who visited the endocrinology outpatient hospital clinic for a routine checkup, or with a non-related to diabetes disease.

Radiation: WHOLE BODY DXA

Interventions

WHOLE BODY DXARADIATION

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

CONTROLSdiabetes mellitus type 2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A group of 36 patients, aged 20-80 years old, 18 male and 17 female with type 2 diabetes mellitus, and a control group with the same demographic characteristics, participated in the study. All were previously examined by an endocrinologist (in a public hospital, private or university outpatient clinic) from March to July 2018. The control group consisted of 14 community people who visited the endocrinology outpatient hospital clinic for a routine checkup, or with a non-related to diabetes disease.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation for Care of Neurological Illnesses, Greece

Athens, Attica, 11256, Greece

Location

Related Publications (2)

  • 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.

    PMID: 31244904BACKGROUND

  • 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. No abstract available.

    PMID: 29518764BACKGROUND

MeSH Terms

Conditions

SarcopeniaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Yannis Dionyssiotis, MD, PhD

    Foundation for Care of Neurological Illnesses, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate student in Hellenic Open University of Greece

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 29, 2020

Study Start

March 20, 2018

Primary Completion

July 31, 2018

Study Completion

September 22, 2018

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations

GR(1)