Screening Patients With Diabetes Mellitus for the Presence of Skin Disorder of Scleredema

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04335396
• Other study ID #: 22400-5/2018 EÜIG
• Status: Recruiting
• Start date: May 28, 2018
• Est. completion date: May 28, 2023

Study information

• Verified date: April 2020
• Source: University of Pecs
• Contact: Cecilia Varju, MD, PhD
• Phone: +36302134820
• Email: varju.cecilia[@]pte.hu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Metabolic and vascular complications of these patients will be focused on.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 28, 2023
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

Patients taking any forms of glucocorticoids in the previous year.

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Scleredema Adultorum
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Scleroderma-Like Changes

Locations

Country	Name	City	State
Hungary	Dept. Rheumatology and Immunology, University of Pécs	Pécs	Baranya

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

References & Publications (5)

Cole 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. — View Citation

Knobler 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, Kähäri V — View Citation

Lee 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. — View Citation

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. — View Citation

Scholz 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. Epub 2016 Oct 7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during the whole study, 60 months
Primary	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.	during the whole study, 60 months
Secondary	Hepatic steatosis index	8×(alanine aminotransferase/aspartate aminotransferase (ALT/AST) ratio) + BMI (+2, if female; +2, if diabetes mellitus)	during the whole study, 60 months
Secondary	Number of vascular complications in patients' medical histories, earlier, than our investigation time	Prevalence of stroke, myocardial infarction, macroangiopathy, nephropathy and retinopathy. neuropathy	during the whole study, 60 months
Secondary	Prevalence of polyneuropathy	assessed by electroneuronography	during the whole study, 60 months