Sexual Dysfunction in Type 2 Diabetic Women

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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Neuropathy

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 Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • IRCCS Policlinico S. Matteo Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Type 2 diabetic women

Description

Inclusion Criteria:

• type 2 diabetes mellitus

Exclusion Criteria:

• previous surgery for hysterectomy or ovariectomy
• hormone replacement

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Type 2 diabetic women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	36 months

Other Outcome Measures

Outcome Measure	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: 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

Collaborators and Investigators

• Sponsor: University of Pavia
• Collaborators: IRCCS Policlinico S. Matteo
• Investigators: Principal Investigator: Giuseppe Derosa, MD, PhD, IRCCS Policlinico S. Matteo

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2013
• Primary Completion (Actual): December 22, 2017
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: July 6, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 21, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20120021266