Sexual Dysfunction in Type 2 Diabetic Women

NCT01896648 | Completed

• 1 other identifier: 20120021266
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus is becoming an increasingly problem for public health and it is related with various complications such as sexual problems. The prevalence of erectile dysfunction has been widely studied in men as a complication of diabetes; the prevalence of sexual dysfunction in women, instead, has not been well investigated. The aim of this study is to evaluate the prevalence of sexual dysfunction in type 2 diabetic women using international validated questionnaires.

Conditions

Sexual Dysfunction; Neuropathy

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index (FSFI)

  Female Sexual Function Index (FSFI) is a 19-item questionnaire, developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women.

  12 months

Secondary Outcomes (1)

• Prevalence of sexual dysfunction risk factors

  36 months

Other Outcomes (1)

• Correlation between sexual dysfunction and diabetic neuropathy

  36 months

Study Arms (1)

Type 2 diabetic women

Eligibility Criteria

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

Study Population

Type 2 diabetic women

You may qualify if:

• type 2 diabetes mellitus

You may not qualify if:

• previous surgery for hysterectomy or ovariectomy
• hormone replacement

Sponsors & Collaborators

• University of Pavia: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

IRCCS Policlinico S. Matteo Foundation

Pavia, 27100, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The following parameters will be assessed: Blood: ematology, glycated hemoglobin, fasting plasma glucose, fasting plasma insulin, total cholesterol, HDL cholesterol, triglycerides, LDL cholesterol, creatinine, urea, transaminases, electrolytes, homocysteine, high sensitivity C-reactive protein (hs-CRP), metalloproteinase-2 (MMP-2), metalloproteinase-9 (MMP-9), soluble adhesion molecules (sICAM-1, sVCAM-1), sE-selectin, lipoprotein (a) \[Lp (a)\], Plasminogen Activator Inhibitor-1 (PAI-1). Urine: complete urinalysis, 24-hour microalbuminuria

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Giuseppe Derosa, MD, PhD

  Fondazione IRCCS Policlinico San Matteo di Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 11, 2013
• Study Start: June 24, 2013
• Primary Completion: December 22, 2017
• Study Completion: March 15, 2018
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

IT (1)