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Completed

NCT Number: NCT01896648

Sexual Dysfunction in Type 2 Diabetic Women

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.

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Key information

Conditions

Sexual Dysfunction Genital Diseases Neuropathy Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Policlinico S. Matteo Foundation

Pavia, 27100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes mellitus

Exclusion criteria

  • previous surgery for hysterectomy or ovariectomy
  • hormone replacement

Treatment and study plan

Primary outcomes

  1. Female Sexual Function Index (FSFI)

    Time frame: 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 outcomes

  1. Prevalence of sexual dysfunction risk factors

    Time frame: 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.

Other outcomes

  1. Correlation between sexual dysfunction and diabetic neuropathy

    Time frame: 36 months

    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

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Jul 11, 2013
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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