Sexual Dysfunction in Type 2 Diabetic Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Pavia
Sponsor:
Collaborator:
IRCCS Policlinico S. Matteo
Information provided by (Responsible Party):
Giuseppe Derosa, University of Pavia
ClinicalTrials.gov Identifier:
NCT01896648
First received: June 25, 2013
Last updated: July 6, 2013
Last verified: July 2013
  Purpose

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.


Condition
Sexual Dysfunction
Neuropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Sexual Dysfunction in Type 2 Diabetic Women: Study on Prevalence and on Risk

Further study details as provided by University of Pavia:

Primary Outcome Measures:
  • Female Sexual Function Index (FSFI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Prevalence of sexual dysfunction risk factors [ Time Frame: 36 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Correlation between sexual dysfunction and diabetic neuropathy [ Time Frame: 36 months ] [ Designated as safety issue: No ]

    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:

    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


Biospecimen Retention:   Samples Without DNA

The following parameters will be assessed:

Blood: ematology, glycated hemoglobin, fasting plasma glucose, fasting plasma insulin, total cholesterol, HDL cholesterol, triglycerides, LDL cholesterol, creatinine, urea, transaminases, electrolytes, 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).

Urine: complete urinalysis, 24-hour microalbuminuria


Estimated Enrollment: 306
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type 2 diabetic women

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Type 2 diabetic women

Criteria

Inclusion Criteria:

  • type 2 diabetes mellitus

Exclusion Criteria:

  • previous surgery for hysterectomy or ovariectomy
  • hormone replacement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896648

Contacts
Contact: Giuseppe Derosa, MD, PhD giuseppe.derosa@unipv.it
Contact: Pamela Maffioli, MD pamelamaffioli@hotmail.it

Locations
Italy
IRCCS Policlinico S. Matteo Foundation Recruiting
Pavia, Italy, 27100
Contact: Giuseppe Derosa, MD, PhD       giuseppe.derosa@unipv.it   
Contact: Pamela Maffioli, MD       pamelamaffioli@hotmail.it   
Principal Investigator: Giuseppe Derosa, MD, PhD         
Sub-Investigator: Pamela Maffioli, MD         
Sponsors and Collaborators
University of Pavia
IRCCS Policlinico S. Matteo
Investigators
Principal Investigator: Giuseppe Derosa, MD, PhD IRCCS Policlinico S. Matteo Foundation
  More Information

No publications provided

Responsible Party: Giuseppe Derosa, Professor, University of Pavia
ClinicalTrials.gov Identifier: NCT01896648     History of Changes
Other Study ID Numbers: 20120021266
Study First Received: June 25, 2013
Last Updated: July 6, 2013
Health Authority: Italy: Ethics Committee

ClinicalTrials.gov processed this record on September 30, 2014