Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients (ECSIITED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Jothydev's Diabetes and Research Centre
Sponsor:
Information provided by (Responsible Party):
Dr. Jothydev Kesavadev, Jothydev's Diabetes and Research Centre
ClinicalTrials.gov Identifier:
NCT01468519
First received: July 2, 2011
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Erectile Dysfunction
Drug: Insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Continuous Subcutaneous Insulin Infusion (CSII) on Erectile Dysfunction in T2DM Patients: A Prospective, Exploratory, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Jothydev's Diabetes and Research Centre:

Primary Outcome Measures:
  • Change in total International Index of Erectile Function (IIEF) score from baseline to six months [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Global assessment question on erectile function [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Global assessment question (GAQ), "Has the treatment you have been having improved your erections? (yes/no)."


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CSII
continuous subcutaneous insulin infusion
Drug: Insulin
Insulin via continuous subcutaneous insulin infusion
Active Comparator: MDI
multiple daily insulin injections
Drug: Insulin
insulin via multiple daily injections

Detailed Description:

Background 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. Neuropathy is a major contributor to diabetic ED. Other causes of ED in diabetes include vascular disease, metabolic control, nutrition, endocrine disorders, psychogenic factors, and drugs.

Continuous Sub-cutaneous Insulin Infusion The Continuous Subcutaneous Insulin Infusion (CSII) Pump (insulin pump for short) is a pager-sized device which can be connected to the body through an infusion set so as to deliver insulin continuously. It consists of a disposable reservoir for insulin, a disposable infusion set, including a cannula for subcutaneous insertion and a tubing system which connects the insulin reservoir to the cannula. Insulin pump therapy by itself is not a new therapy for diabetes mellitus. It is an alternative delivery mechanism for administration of insulin and is found to be superior to ordinary syringes and insulin pens. Insulin pumps were popularly used in T1DM but nowadays insulin pumps are commonly used in T2DM patients as well.

A guideline for use of insulin pumps in India has been recently published in Diabetes Technology and Therapeutics journal, which included participation from Jothydev's Diabetes Center.

Although comparatively costly, advantages of CSII over other modes of insulin delivery include better glycemic control, fewer hypoglycemic episodes, and improved quality of life. Our own center has reported a significant reduction in HbA1c when subjects in multiple daily insulin switched to CSII.

Relevant Clinical Data In the aforementioned study of CSII in Type 2 diabetes patients in our study, 83% of men reported an improvement in sexual function when queried after 6 months on CSII. The mode of improvement and magnitude of this effect is not known, and needs to be ascertained in prospective trials. The present study proposal is to corroborate the findings, and obtain clarification of effect size.

Potential Benefits & Risks The following improvements can be expected following initiation of insulin pump therapy.

  • Improvement in HbA1c
  • Reduction in blood sugar fluctuations
  • Reduction in major and minor hypoglycemic episodes
  • Reduction in total daily dose of insulin
  • Improvement in QOL

The following are some risks/disadvantages of using insulin pump therapy

  • Cost of pumps and consumables is higher than other modes of insulin delivery
  • There is a risk of infection if the cannula is not changed once in every three days.
  • Improper use of insulin pump boluses can lead to insulin stacking and low sugars.

Proper patient education and monitoring will be part of the study to overcome the risks of insulin pump therapy.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01468519

Contacts
Contact: Jothydev Kesavadev, MD 914712356200 jothydev@gmail.com

Locations
India
Jothydev's Diabetes & Research Center Recruiting
Thiruvananthapuram, Kerala, India, 695032
Contact: Krishnan    +919496246200    gopika@jothydev.net   
Principal Investigator: Jothydev Kesavadev, MD         
Sponsors and Collaborators
Jothydev's Diabetes and Research Centre
Investigators
Principal Investigator: Jothydev Kesavadev, MD Jothydev's Diabetes & Research Center
Study Chair: Gopika Krishnan, BPHARM Jothydev's Diabetes & Research Center
  More Information

Publications:
Responsible Party: Dr. Jothydev Kesavadev, CEO & Director., Jothydev's Diabetes and Research Centre
ClinicalTrials.gov Identifier: NCT01468519     History of Changes
Other Study ID Numbers: JDC/Pump/020/2011
Study First Received: July 2, 2011
Last Updated: May 29, 2014
Health Authority: India: Institutional Review Board

Keywords provided by Jothydev's Diabetes and Research Centre:
Diabetes mellitus, type 2
Erectile dysfunction
continuous subcutaneous insulin infusion
CSII
insulin

Additional relevant MeSH terms:
Erectile Dysfunction
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014