Testosterone for Peripheral Vascular Disease

• Sponsor: Barnsley Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00504712
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism; Peripheral Vascular Disease; Type 2 Diabetes	Drug: Testosterone; Drug: saline	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2006
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Testosterone 200 mg intramuscular every 2 weeks	Drug: Testosterone; Sustanon- 200mg- Intramuscular testosterone every 2 weeks
Placebo Comparator: Placebo Saline	Drug: saline; Saline injection every two weeks

Outcome Measures

Primary Outcome Measures

1. Change in Arterial Stiffness [Baseline, 12 weeks, and 26 weeks]

   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

1. Change in IMT [Baseline, 12 weeks, and 26 weeks]

   Progression of Carotid intima-media thickness measured in mm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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).

1. Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.

2. Ability to give written informed consent after verbal and written explanation in the English language.

3. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barnsley Hospital NHS Foundation Trust	Barnsley	South Yorkshire	United Kingdom	S75 2EP

Sponsors and Collaborators

• Barnsley Hospital

Investigators

• Principal Investigator: Thomas H Jones, Barnsley Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barnsley Hospital
• ClinicalTrials.gov Identifier: NCT00504712
• Other Study ID Numbers: 300
• First Posted: Jul 20, 2007
• Last Update Posted: Jun 8, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Barnsley Hospital: Testosterone; Hypogonadism; Diabetes; PVD; RCT
• Additional relevant MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Diabetes Mellitus, Type 2; Hypogonadism; Testosterone

Study Results

Participant Flow

Recruitment Details	started 02/02/2006

Arm/Group Title	Active	Placebo
Arm/Group Description	Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks	Saline saline: Saline injection every two weeks
Period Title: Overall Study
STARTED	11	13
COMPLETED	11	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Active	Placebo	Total
Arm/Group Description	Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks	Saline saline: Saline injection every two weeks	Total of all reporting groups
Overall Participants	11	13	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.6 (11.9)	61.7 (11.8)	59.15 (11.85)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	11 100%	13 100%	24 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active	Placebo
Arm/Group Description	Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks	Saline saline: Saline injection every two weeks
Measure Participants	11	13
Baseline	15.02 (5.74)	15.08 (6.59)
12 weeks	14.08 (5.36)	16.12 (7.42)
26 weeks	14.01 (4.53)	12.58 (5.55)

2. Secondary Outcome

Title	Change in IMT
Description	Progression of Carotid intima-media thickness measured in mm
Time Frame	Baseline, 12 weeks, and 26 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active	Placebo
Arm/Group Description	Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks	Saline saline: Saline injection every two weeks
Measure Participants	11	13
Baseline	0.856 (0.132)	0.885 (0.130)
12 weeks	0.843 (0.137)	0.887 (0.120)
26 weeks	0.841 (0.135)	0.872 (0.124)

Adverse Events

Adverse Event Reporting Description	Specific Adverse Event terms were not used for this study.
Arm/Group Title	Active		Placebo
Arm/Group Description	Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks		Saline saline: Saline injection every two weeks
All Cause Mortality
	Active		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Active		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)		2/13 (15.4%)
Cardiac disorders
Serious	1/11 (9.1%)	1	0/13 (0%)	0
General disorders
Serious	0/11 (0%)	0	1/13 (7.7%)	1
Renal and urinary disorders
Adverse Event	0/11 (0%)	0	1/13 (7.7%)	1
Other (Not Including Serious) Adverse Events
	Active		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/11 (27.3%)		4/13 (30.8%)
General disorders
Adverse Event	1/11 (9.1%)	1	0/13 (0%)	0
Adverse	0/11 (0%)	0	1/13 (7.7%)	1
Adverse	0/11 (0%)	0	1/13 (7.7%)	1
Adverse	0/11 (0%)	0	1/13 (7.7%)	1
Infections and infestations
adverse	0/11 (0%)	0	1/13 (7.7%)	1
Respiratory, thoracic and mediastinal disorders
Adverse	1/11 (9.1%)	1	0/13 (0%)	0
Skin and subcutaneous tissue disorders
Adverse	1/11 (9.1%)	1	0/13 (0%)	0

Limitations/Caveats

It was more difficult than anticipated to recruit patients to the trial and despite extension of the trial beyond expected completion date the target recruitment was not achieved.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.