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

NCT04335396 | Unknown

• 1 other identifier: 22400-5/2018 EÜIG
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Diabetes Complications; Scleroderma-Like Changes; Scleredema Adultorum

Keywords

Scleredema; Scleroderma-like conditions; Dyslipidemia; NAFLD; Metabolic syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Hepatic steatosis index

  during the whole study, 60 months

• Number of vascular complications in patients' medical histories, earlier, than our investigation time

  during the whole study, 60 months

• Prevalence of polyneuropathy

  during the whole study, 60 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients

You may qualify if:

• 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.

You may not qualify if:

• Patients taking any forms of glucocorticoids in the previous year.

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Dept. Rheumatology and Immunology, University of Pécs

Pécs, Baranya, 7634, Hungary

RECRUITING

Related Publications (6)

• 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.

  PMID: 2970922 BACKGROUND

• 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. doi: 10.1159/000450866. Epub 2016 Oct 7.

  PMID: 27921043 BACKGROUND

• 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.

  PMID: 19766548 BACKGROUND

• 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, 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.

  PMID: 28786499 RESULT

• 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. doi: 10.2337/diacare.6.2.189.

  PMID: 6851809 RESULT

• Csonka 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.

  PMID: 33952255 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

skin biopsies

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Complications; Scleredema Adultorum; Dyslipidemias; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lipid Metabolism Disorders; Fatty Liver; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Cecilia Varju, MD, PhD

  Dept. Rheumatology and Immunology, University of Pécs, Hungary

  STUDY CHAIR

Central Study Contacts

Cecilia Varju, MD, PhD

CONTACT

+36302134820; varju.cecilia@pte.hu

Gergő Molnár, MD, PhD, MSc

CONTACT

gergo.molnar@aok.pte.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: May 28, 2018
• Primary Completion: May 30, 2020
• Study Completion: May 28, 2023
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)