Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients

NCT01468519 | Completed Phase 4 DMC

• 1 other identifier: JDC/Pump/020/2011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Erectile Dysfunction

Keywords

Diabetes mellitus, type 2; Erectile dysfunction; continuous subcutaneous insulin infusion; CSII; insulin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Global assessment question on erectile function

  baseline and 6 months

Study Arms (2)

CSII

EXPERIMENTAL

continuous subcutaneous insulin infusion

Drug: Insulin

MDI

ACTIVE COMPARATOR

multiple daily insulin injections

Drug: Insulin

Interventions

Insulin DRUG

Insulin via continuous subcutaneous insulin infusion

CSII

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jothydev's Diabetes and Research Centre: lead

Study Sites (1)

Jothydev's Diabetes & Research Center

Thiruvananthapuram, Kerala, 695032, India

Location

Related Publications (3)

• 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.

  PMID: 20807118 BACKGROUND

• 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: 10.1089/dia.2008.0128.

  PMID: 19698065 RESULT

• Kesavadev J, Sadasivan Pillai PB, Shankar A, Warrier RS, Ramachandran L, Jothydev S, Krishnan G. Exploratory CSII Randomized Controlled Trial on Erectile Dysfunction in T2DM Patients (ECSIITED). J Diabetes Sci Technol. 2018 Nov;12(6):1252-1253. doi: 10.1177/1932296818794704. Epub 2018 Aug 29. No abstract available.

  PMID: 30156866 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Erectile Dysfunction; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jothydev Kesavadev, MD

  Jothydev's Diabetes & Research Center

  PRINCIPAL INVESTIGATOR

• Gopika Krishnan, BPHARM

  Jothydev's Diabetes & Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO & Director.

Study Record Dates

• First Submitted: July 2, 2011
• First Posted: November 9, 2011
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

IN (1)