SarcopeniaSARCoDMNCT04407819
Sarcopenia and Diabetes Mellitus
An observational study of Sarcopenia, run by Dionyssiotis, Yannis, M.D. at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- WHOLE BODY DXA
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 20 Mar 2018to 22 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Foundation for Care of Neurological Illnesses, Greece
Athens, Attica, 11256
About this study
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- WHOLE BODY DXA
- Keywords
- sarcopenia, diabetes mellitus, skeletal muscle index
- Medical subject headings
- Sarcopenia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOLE BODY DXARadiation
Muscle mass was estimated by using the whole body DXA (Hologic Horizon W)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: WHOLE BODY DXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Index
Appendicular Muscle Mass/Height2
Measured: Up to 12 weeks
prevalence of sarcopenia in patients with T2D and in the control group
percents in different groups
Measured: Up to 12 weeks
Secondary outcomes (1)
fat mass
percent of fat mass, Total Fat index
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start20 Mar 2018
- Primary completion31 Jul 2018
- Study completion22 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dionyssiotis, Yannis, M.D.
- Collaborators
- University of Thessaly
- Responsible party
- Principal investigator, Yannis Dionyssiotis, Dionyssiotis, Yannis, M.D.
- Investigators
- Yannis Dionyssiotis, MD, PhD, Principal investigator, Foundation for Care of Neurological Illnesses, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407819
- Sponsor's protocol ID
- EAPDionyssiotis
- Acronym
- SARCoDM
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31244904Dionyssiotis 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.
PubMed 29518764
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia and Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04407819
- Acronym / sponsor ID
- SARCoDM / EAPDionyssiotis
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, diabetes mellitus, skeletal muscle index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dionyssiotis, Yannis, M.D.
- Collaborators
- University of Thessaly
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 22 Sep 2018 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetes mellitus type 2 | – | Radiation: WHOLE BODY DXA36 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 | – | Radiation: WHOLE BODY DXA14 community people who visited the endocrinology outpatient hospital clinic for a routine checkup, or with a non-related to diabetes disease. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHOLE BODY DXAMuscle mass was estimated by using the whole body DXA (Hologic Horizon W) | Radiation | CONTROLS, diabetes mellitus type 2 |
Primary outcome
Skeletal Muscle Index
Time frame: Up to 12 weeks
Appendicular Muscle Mass/Height2
prevalence of sarcopenia in patients with T2D and in the control group
Time frame: Up to 12 weeks
percents in different groups
1 secondary outcome
fat mass
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Background: PubMed 31244904Dionyssiotis 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.
- Background: PubMed 29518764Dionyssiotis 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.
- Individual participant dataSharing planned: Undecided
Related trials for Sarcopenia
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannis Dionyssiotis, MD, PhD principal investigator
Foundation for Care of Neurological Illnesses, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Dionyssiotis, Yannis, M.D. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Index (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04407819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.