Diabetes Mellitus, Type 2 Clinical Trial
— ECSIITEDOfficial title:
Effects of Continuous Subcutaneous Insulin Infusion (CSII) on Erectile Dysfunction in T2DM Patients: A Prospective, Exploratory, Controlled Trial
Erectile dysfunction (ED) is a common form of organic sexual dysfunction in males with diabetes, with estimated incidence rates between 35 and 75%. Fifty percent of men with diabetes are afflicted with ED within 10 years of their diagnosis. Long-term poor glycemic control increases the risk ED. Although comparatively costly, advantages of CSII over other modes of insulin delivery include better glycemic control, fewer hypoglycemic episodes, and improved quality of life. In a previously published study, on CSII in T2DM, in our center, 83% of men reported an improvement in sexual function as a secondary endpoint. The current study is planned to further explore this finding.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 25 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male T2DM patients with HbA1c < 9% - Mild ED to Moderate ED as defined by International Index of Erectile Function (IIEF) questionnaire - Able and willing to use insulin pumps for at least the duration of the study Exclusion Criteria: - Severe dysfunction in IIEF Score or duration of ED more than 3 years - Heart failure (class II - IV) or unstable cardiovascular disease; poorly controlled blood pressure (systolic > 170 or < 90 mmHg or diastolic > 100 or < 50 mmHg) or orthostatic hypotension - Medications: Substance abuse, anticancer and steroid therapy - Sexual dysfunction in partner, lack of stable relationship. - History of radical prostatectomy or pelvic surgery, significant penile deformities, penile implants, or history of stroke or spinal-cord trauma. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Jothydev's Diabetes & Research Center | Thiruvananthapuram | Kerala |
Lead Sponsor | Collaborator |
---|---|
Jothydev's Diabetes and Research Centre |
India,
Kesavadev J, Balakrishnan S, Ahammed S, Jothydev S. Reduction of glycosylated hemoglobin following 6 months of continuous subcutaneous insulin infusion in an Indian population with type 2 diabetes. Diabetes Technol Ther. 2009 Aug;11(8):517-21. doi: 10.108 — View Citation
Kesavadev J, Das AK, Unnikrishnan R 1st, Joshi SR, Ramachandran A, Shamsudeen J, Krishnan G, Jothydev S, Mohan V. Use of insulin pumps in India: suggested guidelines based on experience and cultural differences. Diabetes Technol Ther. 2010 Oct;12(10):823-31. doi: 10.1089/dia.2010.0027. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in total International Index of Erectile Function (IIEF) score from baseline to six months | IIEF quetionnaire is a standardised and validated 15-item self-evaluation scale that provides pre-post treatment clinic evaluations of erectile function, orgasmic function, sexual desire, satisfaction in sexual intercourse and general satisfaction | baseline and six months | No |
Secondary | Global assessment question on erectile function | Global assessment question (GAQ), "Has the treatment you have been having improved your erections? (yes/no)." | baseline and 6 months | No |
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