Diabetes MellitusNCT04335396
Screening Patients With Diabetes Mellitus for the Presence of Skin Disorder of Scleredema
An observational study of Diabetes Mellitus and Diabetes Complications, run by University of Pecs at 1 site in Hungary.
Trial summary
Scleredema is a scleroderma-like skin disorder appearing in 2.5-14% among patients with type 1 or 2 diabetes mellitus. This is a single centre study to screen consecutive patients with diabetes mellitus for the presence of scleredema,and to compare the clinical-laboratory data of patients with and without scleredema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetes Complications, Scleroderma-Like Changes
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- 28 May 2018to 28 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients
Who may be able to join
- Diagnosis of diabetes mellitus is based on the criteria of the World Health Organization (WHO), 2006.
- The duration of diabetes mellitus must be longer than one year.
Who cannot join
- Patients taking any forms of glucocorticoids in the previous year.
Trial locations and contacts
1 site in 1 country.
Gergő Molnár, MD, PhD, MSc contact
Hungary1 site, 1 recruiting
- Recruiting
Dept. Rheumatology and Immunology, University of Pécs
Pécs, Baranya, 7634
Cecília Varjú
About this study
Official title: Screening Patients With Diabetes Mellitus for the Presence of Scleredema Adultorum of Buschke and Characterize Clinical-laboratory Findings of the Newly Identified Cases: a Single-center, Prospective, Obsevational Study
Scleredema is a scleroderma-like skin disorder appearing in 2.5-14% among patients with type 1 or 2 diabetes mellitus. This is a single centre study to screen consecutive patients with diabetes mellitus for the presence of scleredema,and to compare the clinical-laboratory data of patients with and without scleredema. Metabolic and vascular complications of these patients will be focused on.
Read the detailed description
Scleredema adultorum of Buschke is a scleroderma-like skin disorder characterized by thickened skin with edema in patients' neck, shoulders and back. Graff described three types of scleredema. The first type occurs usually in children after an infection, the second type often associated with haematological malignancies and the third type usually develops in patients with long lasting uncontrolled diabetes mellitus. These patients with diabetes are often obese and have vascular complications. Based on two large cohorts, the prevalence of scleredema among patients with diabetes mellitus was 2.5-14.0% .
The aims of this study is to screen consecutive patients with diabetes mellitus for the presence of scleredema skin disorder and to investigate and compare the clinical-laboratory data of patients with and without scleredema. Both the vascular complications in case history and the parameters of lipid and carbohydrate metabolism will be focused on. All findings will also be compared to another cohort of scleredema-diabetes patients who already treated in our tertiary clinical centre of the University of Pécs in Hungary.
Participants and methods:
About 150 consecutive patients with diabetes mellitus are planned to be investigated. Scleredema skin disorder will be screened by palpation of skin on the nape of the neck, the whole trunk and the shoulders by at least two physicians. Newly recognized patients will be asked to give their consent for undergoing skin biopsy.
Planned clinical examinations and biochemical data collection are as follows:
Besides taking case history, patients will have a complete physical examination, and they will be asked to respond some standardized questions about their diabetes-related earlier vascular and neurological complications, as well as about their skin status.
Repeated blood pressure, measuring weight and their height for defining BMI, for the diagnosis of polyneuropathy neurological physical examination, electroneuronography and calibrated tuning-fork test will be done. Retinopathy will be considered based on ophthalmological examination.
Laboratory investigations are planned including blood count, routine chemistry, glycated haemoglobin (HbA1c), parameters of lipid metabolism as well as thyroid stimulating hormone (TSH) test, unless the patient already had results for these particular lab tests less than three months before. Significant nephropathy will be recorded based on values lower than 60 ml/min/1.73m2 of estimated glomerular filtration rate (eGFR) or the presence of microalbuminuria (>300 mg/die). Calculating of Hepatic steatosis index (HSI) and Framingham steatosis index (FrSI) for define the presence of non-alcoholic fatty liver disease (NAFLD) are also planned.
Statistical analysis of the results will be performed: The distribution of variables planned to be evaluated based on Kolmogorov-Smirnov's test. Comparisons of the values of clinical data between groups will be performed by using a Kruskal-Wallis test for non-parametric data or a one-way ANOVA test for normally distributed continuous variables; Bonferonni's post hoc tests will be used in all cases. Chi-square test or Fisher's test will be used for categorical variables. Clinical-laboratory parameters associated with developing scleredema skin disorder are planned to defined by binary logistic regression with stepwise selection. Statistical analyses will be performed with IBM SPSS Statistics v 24.0 software package (IBM's Corporate, New York, USA).
- Keywords
- Scleredema, Scleroderma-like conditions, Dyslipidemia, NAFLD, Metabolic syndrome
- Medical subject headings
- Diabetes Mellitus, Diabetes Complications, Scleredema Adultorum, Dyslipidemias, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adult patients with diabetes mellitus | Subgroup 1 - consecutive patients with diabetes mellitus with scleredema skin disorder Subgroup 2 - consecutive patients with diabetes mellitus without scleredema Subgroup 3 - patients with diabetes and scleredema - already cared in the tertiary center of the Rheumatology Department of the University of Pécs, in Hungary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of atherogen dyslipidemia
elevated triglycerides (≥1.7 mmol/l) and decreased HDL-cholesterol (<1.03 mmol/l in males and <1.29 mmol/l in females) in the sera
Measured: during the whole study, 60 months
presence of incresed non-HDL cholesterol level of the sera
Serum non-HDL cholesterol was calculated by subtracting HDL-cholesterol from the total cholesterol levels of the sera.
Measured: during the whole study, 60 months
Secondary outcomes (3)
Hepatic steatosis index
8×(alanine aminotransferase/aspartate aminotransferase (ALT/AST) ratio) + BMI (+2, if female; +2, if diabetes mellitus)
Measured: during the whole study, 60 months
Number of vascular complications in patients' medical histories, earlier, than our investigation time
Prevalence of stroke, myocardial infarction, macroangiopathy, nephropathy and retinopathy. neuropathy
Measured: during the whole study, 60 months
Prevalence of polyneuropathy
assessed by electroneuronography
Measured: during the whole study, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start28 May 2018
- Primary completion30 May 2020 (estimated)
- Study completion28 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr Varjú Cecília, University of Pecs
- Investigators
- Cecilia Varju, MD, PhD, Study chair, Dept. Rheumatology and Immunology, University of Pécs, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335396
- Sponsor's protocol ID
- 22400-5/2018 EÜIG
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sattar MA, Diab S, Sugathan TN, Sivanandasingham P, Fenech FF. Scleroedema diabeticorum: a minor but often unrecognized complication of diabetes mellitus. Diabet Med. 1988 Jul-Aug;5(5):465-8. doi: 10.1111/j.1464-5491.1988.tb01030.x.
PubMed 2970922Scholz GH, Hanefeld M. Metabolic Vascular Syndrome: New Insights into a Multidimensional Network of Risk Factors and Diseases. Visc Med. 2016 Oct;32(5):319-326. doi: 10.1159/000450866. Epub 2016 Oct 7.
PubMed 27921043Lee JH, Kim D, Kim HJ, Lee CH, Yang JI, Kim W, Kim YJ, Yoon JH, Cho SH, Sung MW, Lee HS. Hepatic steatosis index: a simple screening tool reflecting nonalcoholic fatty liver disease. Dig Liver Dis. 2010 Jul;42(7):503-8. doi: 10.1016/j.dld.2009.08.002. Epub 2009 Sep 18.
PubMed 19766548Knobler R, Moinzadeh P, Hunzelmann N, Kreuter A, Cozzio A, Mouthon L, Cutolo M, Rongioletti F, Denton CP, Rudnicka L, Frasin LA, Smith V, Gabrielli A, Aberer E, Bagot M, Bali G, Bouaziz J, Braae Olesen A, Foeldvari I, Frances C, Jalili A, Just U, Kahari V, Karpati S, Kofoed K, Krasowska D, Olszewska M, Orteu C, Panelius J, Parodi A, Petit A, Quaglino P, Ranki A, Sanchez Schmidt JM, Seneschal J, Skrok A, Sticherling M, Sunderkotter C, Taieb A, Tanew A, Wolf P, Worm M, Wutte NJ, Krieg T. European dermatology forum S1-guideline on the diagnosis and treatment of sclerosing diseases of the skin, Part 2: Scleromyxedema, scleredema and nephrogenic systemic fibrosis. J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1581-1594. doi: 10.1111/jdv.14466. Epub 2017 Aug 8.
PubMed 28786499Cole GW, Headley J, Skowsky R. Scleredema diabeticorum: a common and distinct cutaneous manifestation of diabetes mellitus. Diabetes Care. 1983 Mar-Apr;6(2):189-92. doi: 10.2337/diacare.6.2.189.
PubMed 6851809Csonka V, Bodis B, Kovacs D, Farkas N, Kalman E, Czirjak L, Varju C. Screening for the presence of scleroedema adultorum of Buschke in patients with diabetes mellitus: newly diagnosed patients had a high prevalence of dyslipidaemia. Lipids Health Dis. 2021 May 5;20(1):47. doi: 10.1186/s12944-021-01473-1.
PubMed 33952255
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Patients With Diabetes Mellitus for the Presence of Scleredema Adultorum of Buschke and Characterize Clinical-laboratory Findings of the Newly Identified Cases: a Single-center, Prospective, Obsevational Study
- ClinicalTrials.gov ID
- NCT04335396
- Acronym / sponsor ID
- 22400-5/2018 EÜIG
- Keywords
- Scleredema, Scleroderma-like conditions, Dyslipidemia, NAFLD, Metabolic syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 28 May 2023 (estimated)
- First posted
- 6 Apr 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.
Scleredema is a scleroderma-like skin disorder appearing in 2.5-14% among patients with type 1 or 2 diabetes mellitus. This is a single centre study to screen consecutive patients with diabetes mellitus for the presence of scleredema,and to compare the clinical-laboratory data of patients with and without scleredema. Metabolic and vascular complications of these patients will be focused on.
Detailed description
Scleredema adultorum of Buschke is a scleroderma-like skin disorder characterized by thickened skin with edema in patients' neck, shoulders and back. Graff described three types of scleredema. The first type occurs usually in children after an infection, the second type often associated with haematological malignancies and the third type usually develops in patients with long lasting uncontrolled diabetes mellitus. These patients with diabetes are often obese and have vascular complications. Based on two large cohorts, the prevalence of scleredema among patients with diabetes mellitus was 2.5-14.0% .
The aims of this study is to screen consecutive patients with diabetes mellitus for the presence of scleredema skin disorder and to investigate and compare the clinical-laboratory data of patients with and without scleredema. Both the vascular complications in case history and the parameters of lipid and carbohydrate metabolism will be focused on. All findings will also be compared to another cohort of scleredema-diabetes patients who already treated in our tertiary clinical centre of the University of Pécs in Hungary.
Participants and methods:
About 150 consecutive patients with diabetes mellitus are planned to be investigated. Scleredema skin disorder will be screened by palpation of skin on the nape of the neck, the whole trunk and the shoulders by at least two physicians. Newly recognized patients will be asked to give their consent for undergoing skin biopsy.
Planned clinical examinations and biochemical data collection are as follows:
Besides taking case history, patients will have a complete physical examination, and they will be asked to respond some standardized questions about their diabetes-related earlier vascular and neurological complications, as well as about their skin status.
Repeated blood pressure, measuring weight and their height for defining BMI, for the diagnosis of polyneuropathy neurological physical examination, electroneuronography and calibrated tuning-fork test will be done. Retinopathy will be considered based on ophthalmological examination.
Laboratory investigations are planned including blood count, routine chemistry, glycated haemoglobin (HbA1c), parameters of lipid metabolism as well as thyroid stimulating hormone (TSH) test, unless the patient already had results for these particular lab tests less than three months before. Significant nephropathy will be recorded based on values lower than 60 ml/min/1.73m2 of estimated glomerular filtration rate (eGFR) or the presence of microalbuminuria (>300 mg/die). Calculating of Hepatic steatosis index (HSI) and Framingham steatosis index (FrSI) for define the presence of non-alcoholic fatty liver disease (NAFLD) are also planned.
Statistical analysis of the results will be performed: The distribution of variables planned to be evaluated based on Kolmogorov-Smirnov's test. Comparisons of the values of clinical data between groups will be performed by using a Kruskal-Wallis test for non-parametric data or a one-way ANOVA test for normally distributed continuous variables; Bonferonni's post hoc tests will be used in all cases. Chi-square test or Fisher's test will be used for categorical variables. Clinical-laboratory parameters associated with developing scleredema skin disorder are planned to defined by binary logistic regression with stepwise selection. Statistical analyses will be performed with IBM SPSS Statistics v 24.0 software package (IBM's Corporate, New York, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with diabetes mellitus | – | –Subgroup 1 - consecutive patients with diabetes mellitus with scleredema skin disorder Subgroup 2 - consecutive patients with diabetes mellitus without scleredema Subgroup 3 - patients with diabetes and scleredema - already cared in the tertiary center of the Rheumatology Department of the University of Pécs, in Hungary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients
Key inclusion criteria (2 listed)
- Diagnosis of diabetes mellitus is based on the criteria of the World Health Organization (WHO), 2006.
- The duration of diabetes mellitus must be longer than one year.
Key exclusion criteria (1 listed)
- Patients taking any forms of glucocorticoids in the previous year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
presence of atherogen dyslipidemia
Time frame: during the whole study, 60 months
elevated triglycerides (≥1.7 mmol/l) and decreased HDL-cholesterol (<1.03 mmol/l in males and <1.29 mmol/l in females) in the sera
presence of incresed non-HDL cholesterol level of the sera
Time frame: during the whole study, 60 months
Serum non-HDL cholesterol was calculated by subtracting HDL-cholesterol from the total cholesterol levels of the sera.
3 secondary outcomes
Hepatic steatosis index
Time frame: during the whole study, 60 months
Number of vascular complications in patients' medical histories, earlier, than our investigation time
Time frame: during the whole study, 60 months
Prevalence of polyneuropathy
Time frame: during the whole study, 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Background: PubMed 2970922Sattar MA, Diab S, Sugathan TN, Sivanandasingham P, Fenech FF. Scleroedema diabeticorum: a minor but often unrecognized complication of diabetes mellitus. Diabet Med. 1988 Jul-Aug;5(5):465-8. doi: 10.1111/j.1464-5491.1988.tb01030.x.
- Background: PubMed 27921043Scholz GH, Hanefeld M. Metabolic Vascular Syndrome: New Insights into a Multidimensional Network of Risk Factors and Diseases. Visc Med. 2016 Oct;32(5):319-326. doi: 10.1159/000450866. Epub 2016 Oct 7.
- Background: PubMed 19766548Lee JH, Kim D, Kim HJ, Lee CH, Yang JI, Kim W, Kim YJ, Yoon JH, Cho SH, Sung MW, Lee HS. Hepatic steatosis index: a simple screening tool reflecting nonalcoholic fatty liver disease. Dig Liver Dis. 2010 Jul;42(7):503-8. doi: 10.1016/j.dld.2009.08.002. Epub 2009 Sep 18.
- Results publication: PubMed 28786499Knobler R, Moinzadeh P, Hunzelmann N, Kreuter A, Cozzio A, Mouthon L, Cutolo M, Rongioletti F, Denton CP, Rudnicka L, Frasin LA, Smith V, Gabrielli A, Aberer E, Bagot M, Bali G, Bouaziz J, Braae Olesen A, Foeldvari I, Frances C, Jalili A, Just U, Kahari V, Karpati S, Kofoed K, Krasowska D, Olszewska M, Orteu C, Panelius J, Parodi A, Petit A, Quaglino P, Ranki A, Sanchez Schmidt JM, Seneschal J, Skrok A, Sticherling M, Sunderkotter C, Taieb A, Tanew A, Wolf P, Worm M, Wutte NJ, Krieg T. European dermatology forum S1-guideline on the diagnosis and treatment of sclerosing diseases of the skin, Part 2: Scleromyxedema, scleredema and nephrogenic systemic fibrosis. J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1581-1594. doi: 10.1111/jdv.14466. Epub 2017 Aug 8.
- Results publication: PubMed 6851809Cole GW, Headley J, Skowsky R. Scleredema diabeticorum: a common and distinct cutaneous manifestation of diabetes mellitus. Diabetes Care. 1983 Mar-Apr;6(2):189-92. doi: 10.2337/diacare.6.2.189.
- Derived from this study: PubMed 33952255Csonka V, Bodis B, Kovacs D, Farkas N, Kalman E, Czirjak L, Varju C. Screening for the presence of scleroedema adultorum of Buschke in patients with diabetes mellitus: newly diagnosed patients had a high prevalence of dyslipidaemia. Lipids Health Dis. 2021 May 5;20(1):47. doi: 10.1186/s12944-021-01473-1.
- Individual participant dataSharing planned: No
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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.
Gergő Molnár, MD, PhD, MSc contact
Cecilia Varju, MD, PhD study chair
Dept. Rheumatology and Immunology, University of Pécs, Hungary
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 Diabetes Mellitus and Diabetes Complications, run by University of Pecs at 1 site in Hungary.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Apr 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Varju, MD, PhD (+36302134820, varju.cecilia@pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of atherogen dyslipidemia (time frame: during the whole study, 60 months). 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 NCT04335396, which also lists 6 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 8 Apr 2020.