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| Name | Class |
|---|---|
| Fondazione IRCCS Policlinico San Matteo di Pavia | OTHER |
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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.
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:
We will also evaluate the presence of neuropathy through the administration of the Michigan Neuropathy Screening Instrument (MNSI) and the Neuropathy Disability Score (NDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetic women |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of sexual dysfunction risk factors | We will consider the following risk factors: Smoking status; Consume of alcohol; Obesity; Hepatic steatosis; Hypertension; Dyslipidemia; Chronic ischemic disease; Hyperuricemia; Chronic kidney disease; Retinopathy; Neuropathy; Vasculopathy. Correlations between sexual dysfunction and single risk factors will be analyzed using the Pearson correlation coefficient r. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between sexual dysfunction and diabetic neuropathy | The presence of diabetic neuropathy will be assessed using dysautonomic tests (deep breathing, lying to standing, Valsalva maneuver e orthostatic hypotension). The prevalence of symmetric distal neuropathy will be assessed using:
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Inclusion Criteria:
Exclusion Criteria:
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Type 2 diabetic women
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Derosa, MD, PhD | Fondazione IRCCS Policlinico San Matteo di Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico S. Matteo Foundation | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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
| 36 months |
| 36 months |