Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

Barnsley Hospital

Status and phase: Completed; Phase 4

Conditions: Peripheral Vascular Disease; Diabetes Mellitus

Treatments: Drug: Testosterone; Drug: 0.9% saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00355537

BDGH 237

Details and patient eligibility

About

Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima -media thickness which are also related to severity of the clinical syndrome of PVD. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to assess the effect of testosterone treatment on PVD arterial stiffness and intima-media thickness in men with type 2 diabetes and hypogonadism,

Enrollment: 19 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients greater than 18 years of age
• Type 2 Diabetes Mellitus
• Serum testosterone less than 11 nmol/L on two consecutive samples taken on different days
• Peripheral vascular disease as defined by ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene
• Agreement to maintain antihypertensive and anti-lipid treatments at prior doses during 3 months of study
• Ability to give written informed consent after verbal and written explanation in the English Language
• Ability to comply with all study requirements

Exclusion criteria

• Current or previous breast cancer
• Current or previous prostate cancer
• Raised prostate specific antigen or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion
• Severe symptoms of benign prostatic hypertrophy ('prostatism')
• Treatment with testosterone in the 3 months prior to the trial
• Investigational drug treatment in the 3 months prior to the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 2 patient groups, including a placebo group

Active

Experimental group

Treatment:

Drug: Testosterone

Placebo

Placebo Comparator group

Treatment:

Drug: 0.9% saline