Skip to content

Sexual Dysfunction in Type 2 Diabetic Women

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01896648
Enrollment
81
Registered
2013-07-11
Start date
2013-06-24
Completion date
2018-03-15
Last updated
2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathy, Sexual Dysfunction

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).

Interventions

None listed

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
CollaboratorOTHER
University of Pavia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* type 2 diabetes mellitus

Exclusion criteria

* previous surgery for hysterectomy or ovariectomy * hormone replacement

Design outcomes

Primary

MeasureTime frameDescription
Female Sexual Function Index (FSFI)12 monthsFemale 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

MeasureTime frameDescription
Prevalence of sexual dysfunction risk factors36 monthsWe 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.

Other

MeasureTime frameDescription
Correlation between sexual dysfunction and diabetic neuropathy36 monthsThe 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: 1. the Neuropad test, developed as a simple visual indicator test to evaluate diabetic neuropathy 2. the Michigan Neuropathy Screening Instrument (MNSI) 3. the Neuropathy Disability Score (NDS) The correlation will be analyzed using the Pearson correlation coefficient r

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026