Sexual Dysfunction in Type 2 Diabetic Women

Completed

• Conditions: Sexual Dysfunction; Neuropathy

• Registration Number: NCT01896648
• Lead Sponsor: University of Pavia

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).

Study Timeline

• Study Start: 2013-06-24
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-07-06
• Study First Posted: 2013-07-11
• Primary Completion: 2017-12-22
• Study Completion: 2018-03-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-21
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

• type 2 diabetes mellitus

Exclusion Criteria

• previous surgery for hysterectomy or ovariectomy
• hormone replacement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Female Sexual Function Index (FSFI)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of sexual dysfunction risk factors	36 months	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.

Trial Locations

Locations (1)

IRCCS Policlinico S. Matteo Foundation; 🇮🇹 Pavia, Italy