Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

• Sponsor: University at Buffalo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00350701
• Collaborator: Solvay Pharmaceuticals (Industry)
• Enrollment: 49
• Location: 1
• Arms: 3
• Duration (Months): 84
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2	Drug: androgel; Drug: androgel 10g; Drug: placebo	Phase 4

Detailed Description

Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress. Hypogonadism( low testosterone) is also associated with increased levels of inflammatory mediators and atherosclerosis.

This project is about studying the effect of testosterone replacement on different inflammatory cells in blood and urine. It will also compare the dose dependent effect on inflammatory cells. This also involves comparing level of inflammation in hypogonadic diabetic males treated with testosterone with those not treated with any replacement therapy.

This study involves applying AndroGel for 8 wks and studying effects during this time and thereafter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Diagnostic
• Official Title: Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: androgel 5g androgel 5g	Drug: androgel; androgel 5g
Experimental: androgel 10g androgel 10g	Drug: androgel 10g; androgel 10g; Other Names: androgel
Placebo Comparator: placebo placebo	Drug: placebo; placebo

Outcome Measures

Primary Outcome Measures

1. Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo [8 weeks]

   To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups

Secondary Outcome Measures

1. Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo [8 weeks]

   Comparison of relative percent change from baseline at 8 weeks in reactive oxygen species generation (measured as arbitrary units normalized to 100% at baseline) in mononuclear cells after either AndroGel or placebo using chemiluminescence PMSF activation assay. Values at 8 weeks are converted to percentage of the baseline and compared between the groups

2. Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone [8 week]

   To measure the relative percent change from baseline in the inflammatory mediator (CRP) at 8 weeks (values in ng/ml normalized to100% at baseline) following treatment with androgel compared to placebo. Values (in ng/ml) are converted to percentage of baseline at 8 weeks.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males with age 35-75 years inclusive.

• Evidence of hypogonadism: low free testosterone.

• Type 2 Diabetes

• People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.

• If currently on testosterone replacement,testosterone treatment will be held for 8 weeks.

• BP under control even if on medication.

Exclusion Criteria:

• Coronary event or procedure in previous past 4 wks.

• High PSA

• H/O prostate cancer

• Hepatic or renal disease

• Participation in any other concurrent clinical trial

• Any other life- threatening , non cardiac disease.

• Uncontrolled BP

• Congestive heart failure

• High hemoglobin

• Use of investigational agent or therapeutic regimen within 30 days of study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes-Endocrinology Center of Western NY, 115 flint road	Buffalo	New York	United States	14221

Sponsors and Collaborators

• University at Buffalo
• Solvay Pharmaceuticals

Investigators

• Principal Investigator: Paresh Dandona, MD, Kaleida Health/Diabetes Endocrinology Center of WNY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paresh Dandona, MD, University at Buffalo
• ClinicalTrials.gov Identifier: NCT00350701
• Other Study ID Numbers: 1911
• First Posted: Jul 11, 2006
• Last Update Posted: Feb 10, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Paresh Dandona, MD, University at Buffalo: DM type 2; Hypogonadism; Testosterone; AndroGel
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Hypogonadism; Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate

Study Results

Participant Flow

Arm/Group Title	Androgel 5g	Androgel 10g	Placebo
Arm/Group Description	androgel 5g androgel: androgel 5g	androgel 10g androgel 10g: androgel 10g	placebo placebo: placebo
Period Title: Overall Study
STARTED	17	17	15
COMPLETED	17	17	15
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Androgel 5g	Androgel 10g	Placebo	Total
Arm/Group Description	androgel 5g androgel: androgel 5g	androgel 10g androgel 10g: androgel 10g	placebo placebo: placebo	Total of all reporting groups
Overall Participants	17	17	15	49
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	13 76.5%	14 82.4%	12 80%	39 79.6%
>=65 years	4 23.5%	3 17.6%	3 20%	10 20.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (8)	57 (9)	59 (9)	58 (9)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	17 100%	17 100%	15 100%	49 100%

Outcome Measures

1. Primary Outcome

Title	Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo
Description	To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel 5g	Androgel 10g	Placebo
Arm/Group Description	androgel 5g androgel: androgel 5g	androgel 10g androgel 10g: androgel 10g	placebo placebo: placebo
Measure Participants	17	17	15
baseline	100 (0)	100 (0)	100 (0)
8 week	236 (197)	82 (61)	100 (103)

2. Secondary Outcome

Title	Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo
Description	Comparison of relative percent change from baseline at 8 weeks in reactive oxygen species generation (measured as arbitrary units normalized to 100% at baseline) in mononuclear cells after either AndroGel or placebo using chemiluminescence PMSF activation assay. Values at 8 weeks are converted to percentage of the baseline and compared between the groups
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel 5g	Androgel 10g	Placebo
Arm/Group Description	androgel 5g androgel: androgel 5g	androgel 10g androgel 10g: androgel 10g	placebo placebo: placebo
Measure Participants	17	17	15
baseline	100 (0)	100 (0)	100 (0)
8 week	91 (8)	125 (17)	110 (17)

3. Secondary Outcome

Title	Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone
Description	To measure the relative percent change from baseline in the inflammatory mediator (CRP) at 8 weeks (values in ng/ml normalized to100% at baseline) following treatment with androgel compared to placebo. Values (in ng/ml) are converted to percentage of baseline at 8 weeks.
Time Frame	8 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel 5g	Androgel 10g	Placebo
Arm/Group Description	androgel 5g androgel: androgel 5g	androgel 10g androgel 10g: androgel 10g	placebo placebo: placebo
Measure Participants	17	17	15
baseline	100 (0)	100 (0)	100 (0)
8 week	68 (9)	130 (18)	95 (10)

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Androgel 5g		Androgel 10g		Placebo
Arm/Group Description	androgel 5g androgel: androgel 5g		androgel 10g androgel 10g: androgel 10g		placebo placebo: placebo
All Cause Mortality
	Androgel 5g		Androgel 10g		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/15 (0%)
Serious Adverse Events
	Androgel 5g		Androgel 10g		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Androgel 5g		Androgel 10g		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

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.