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Testosterone for Peripheral Vascular Disease

Primary Purpose

Hypogonadism, Peripheral Vascular Disease, Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Testosterone
saline
Sponsored by
Barnsley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Testosterone, Hypogonadism, Diabetes, PVD, RCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Type 2 diabetes mellitus.
  2. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.

  3. Peripheral vascular disease as defined by

    • previous diagnosis by a specialist vascular surgeon OR
    • ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene).
  4. Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.
  5. Ability to give written informed consent after verbal and written explanation in the English language.
  6. Ability to comply with all study requirements.

Exclusion Criteria:

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

Sites / Locations

  • Barnsley Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Testosterone 200 mg intramuscular every 2 weeks

Saline

Outcomes

Primary Outcome Measures

Change in Arterial Stiffness
The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist.

Secondary Outcome Measures

Change in IMT
Progression of Carotid intima-media thickness measured in mm

Full Information

First Posted
July 19, 2007
Last Updated
May 18, 2022
Sponsor
Barnsley Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00504712
Brief Title
Testosterone for Peripheral Vascular Disease
Official Title
A Randomised, Double Blind, Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barnsley Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.
Detailed Description
Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Peripheral Vascular Disease, Type 2 Diabetes
Keywords
Testosterone, Hypogonadism, Diabetes, PVD, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Testosterone 200 mg intramuscular every 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Drug
Intervention Name(s)
Testosterone
Intervention Description
Sustanon- 200mg- Intramuscular testosterone every 2 weeks
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
Saline injection every two weeks
Primary Outcome Measure Information:
Title
Change in Arterial Stiffness
Description
The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist.
Time Frame
Baseline, 12 weeks, and 26 weeks
Secondary Outcome Measure Information:
Title
Change in IMT
Description
Progression of Carotid intima-media thickness measured in mm
Time Frame
Baseline, 12 weeks, and 26 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes mellitus. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism. Peripheral vascular disease as defined by previous diagnosis by a specialist vascular surgeon OR 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 antilipid treatments at prior doses during 3 month duration 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 (PSA) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H Jones
Organizational Affiliation
Barnsley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnsley Hospital NHS Foundation Trust
City
Barnsley
State/Province
South Yorkshire
ZIP/Postal Code
S75 2EP
Country
United Kingdom

12. IPD Sharing Statement

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Testosterone for Peripheral Vascular Disease

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