Diabetes Mellitus Type 2Phase 4NCT00350701
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
A Phase 4 study testing androgel and androgel 10g in people with Diabetes Mellitus Type 2, run by University at Buffalo at 1 site in United States.
Trial summary
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels. Read more about this study
- Who is it for?
- Ages 35 to 75 years, men only
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- androgel and androgel 10g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Uncontrolled BP
- Congestive heart failure
- High hemoglobin
- Use of investigational agent or therapeutic regimen within 30 days of study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes-Endocrinology Center of Western NY, 115 flint road
Buffalo, New York, 14221
About this study
Official title: Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- androgel, androgel 10g, placebo
- Keywords
- DM type 2, Hypogonadism, Testosterone, AndroGel
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
androgelDrug
androgel 5g
androgel 10gDrug
Also called androgel
androgel 10g
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| androgel 5g | Experimental | androgel 5g Receives: Drug: androgel |
| androgel 10g | Experimental | androgel 10g Receives: Drug: androgel 10g |
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo
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
Measured: 8 weeks
Secondary outcomes (2)
Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo
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
Measured: 8 weeks
Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone
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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Responsible party
- Principal investigator, Paresh Dandona, University at Buffalo
- Investigators
- Paresh Dandona, MD, Principal investigator, Kaleida Health/Diabetes Endocrinology Center of WNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350701
- Sponsor's protocol ID
- 1911
- Status last verified
- Jan 2022
- First submitted
- 10 Jul 2006
- Last updated
- 10 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism
- ClinicalTrials.gov ID
- NCT00350701
- Acronym / sponsor ID
- 1911
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- DM type 2, Hypogonadism, Testosterone, AndroGel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Jul 2006
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Jul 2006 (estimated)
- Results
- Posted 10 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| androgel 5g | Experimental | Drug: androgelandrogel 5g |
| androgel 10g | Experimental | Drug: androgel 10gandrogel 10g |
| placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| androgelandrogel 5g | Drug | androgel 5g |
| androgel 10gAlso: androgelandrogel 10g | Drug | androgel 10g |
| placeboplacebo | Drug | placebo |
Primary outcome
Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo
Time frame: 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
2 secondary outcomes
Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo
Time frame: 8 weeks
Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone
Time frame: 8 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paresh Dandona, MD principal investigator
Kaleida Health/Diabetes Endocrinology Center of WNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing androgel and androgel 10g in people with Diabetes Mellitus Type 2, run by University at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.