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

April 6, 2020 updated by: dr Varjú Cecília, University of Pecs

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7634
        • Recruiting
        • Dept. Rheumatology and Immunology, University of Pécs
        • Contact:
          • Cecília Varjú

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the whole study, 60 months
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.
during the whole study, 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic steatosis index
Time Frame: during the whole study, 60 months
8×(alanine aminotransferase/aspartate aminotransferase (ALT/AST) ratio) + BMI (+2, if female; +2, if diabetes mellitus)
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 stroke, myocardial infarction, macroangiopathy, nephropathy and retinopathy. neuropathy
during the whole study, 60 months
Prevalence of polyneuropathy
Time Frame: during the whole study, 60 months
assessed by electroneuronography
during the whole study, 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Investigators

  • Study Chair: Cecilia Varju, MD, PhD, Dept. Rheumatology and Immunology, University of Pécs, Hungary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2018

Primary Completion (Anticipated)

May 30, 2020

Study Completion (Anticipated)

May 28, 2023

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22400-5/2018 EÜIG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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