Clinical trial NCT01896648: Sexual Dysfunction in Type 2 Diabetic Women
Official title: Sexual Dysfunction in Type 2 Diabetic Women: Study on Prevalence and on Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunction
Neuropathy
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2013-07-11
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetic women

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.

Detailed description: In an estimated temporal space of about 3 years, 306 women will be recruited consecutively.

After collection of written informed consent, the following data will be collected:

* History: type of diabetes, comorbidities, current medication, duration of diabetes and complications, voluptuary habits such as tobacco smoke (both number of packets/year and n° packets/day), alcohol consumption, coffee consumption, physical activity.
* Physical exam, general anthropometric parameters such as weight, height, circumference, body mass index, waist-hip ratio, and blood pressure.
* Assessment of glycemic variability (fasting plasma glucose and post-prandial glucose)
* Each patient will be self-administered Female Sexual Function Index (FSFI) and Female Sexual Distress Scale (FSDS) questionnaires to assess the prevalence of sexual dysfunction and Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) of Zung for an accurate assessment of the state of anxiety and depression.
* We will collect blood and urine samples to assess: ematology, glycated hemoglobin, fasting plasma glucose, fasting plasma insulin, total cholesterol, HDL cholesterol, triglycerides, LDL cholesterol, creatinine, urea, transaminases, electrolytes, complete urinalysis, 24-hour microalbuminuria, 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).
* We will also conduct a clinical and instrumental exam of the foot using Neuropad, recently validated as a screening tool for diabetic neuropathy. Patients will also undergo autonomic tests (deep breathing, lying to standing, Valsalva maneuver, and orthostatic hypotension).

We will also evaluate the presence of neuropathy through the administration of the Michigan Neuropathy Screening Instrument (MNSI) and the Neuropathy Disability Score (NDS).

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus

Exclusion Criteria:

* previous surgery for hysterectomy or ovariectomy
* hormone replacement

Primary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: 12 months
Secondary outcomes:
measure: Prevalence of sexual dysfunction risk factors
timeFrame: 36 months
Other outcomes:
measure: Correlation between sexual dysfunction and diabetic neuropathy
timeFrame: 36 months
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo Foundation
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Giuseppe Derosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: