Sexual Dysfunction in Type 2 Diabetic Women

Sexual Dysfunction Clinical Trial

Official title:

Sexual Dysfunction in Type 2 Diabetic Women: Study on Prevalence and on Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896648
• Other study ID #: 20120021266
• Status: Completed
• Start date: June 24, 2013
• Est. completion date: March 15, 2018

Study information

• Verified date: May 2022
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 15, 2018
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• type 2 diabetes mellitus

Exclusion Criteria:

• previous surgery for hysterectomy or ovariectomy

• hormone replacement

Related Conditions & MeSH terms

• Neuropathy
• Sexual Dysfunction

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S. Matteo Foundation	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
University of Pavia	IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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: the Neuropad test, developed as a simple visual indicator test to evaluate diabetic neuropathy; the Michigan Neuropathy Screening Instrument (MNSI); the Neuropathy Disability Score (NDS) The correlation will be analyzed using the Pearson correlation coefficient r	36 months
Primary	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	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.	36 months