Sexual Dysfunction in Type 2 Diabetic Women
|ClinicalTrials.gov Identifier: NCT01896648|
Recruitment Status : Unknown
Verified July 2013 by Giuseppe Derosa, University of Pavia.
Recruitment status was: Recruiting
First Posted : July 11, 2013
Last Update Posted : July 11, 2013
|Condition or disease|
|Sexual Dysfunction Neuropathy|
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|
|Estimated Enrollment :||306 participants|
|Official Title:||Sexual Dysfunction in Type 2 Diabetic Women: Study on Prevalence and on Risk|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||June 2016|
|Type 2 diabetic women|
- 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.
- 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.
- 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
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896648
|Contact: Giuseppe Derosa, MD, PhDfirstname.lastname@example.org|
|Contact: Pamela Maffioli, MDemail@example.com|
|IRCCS Policlinico S. Matteo Foundation||Recruiting|
|Pavia, Italy, 27100|
|Contact: Giuseppe Derosa, MD, PhD firstname.lastname@example.org|
|Contact: Pamela Maffioli, MD email@example.com|
|Principal Investigator: Giuseppe Derosa, MD, PhD|
|Sub-Investigator: Pamela Maffioli, MD|
|Principal Investigator:||Giuseppe Derosa, MD, PhD||IRCCS Policlinico S. Matteo|