Hypogonadotropic HypogonadismPhase 2NCT01155518
Hypogonadism in Young Men With Type 2 Diabetes
A Phase 2 study testing testosterone and clomiphene in people with Hypogonadotropic Hypogonadism and Type 2 Diabetes, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Hypogonadotropic Hypogonadism, Type 2 Diabetes
- What is being tested?
- testosterone and clomiphene
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2013
- Phase
- Phase 2
- 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 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- T2D Males with age 18-40 years
Who cannot join
- planning to have children in the next one year
- Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
- PSA > 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
- Hemoglobin A1c > 8%
- Hematocrit > 50%
- History of obstructive sleep apnea
Show all 16Show fewer
- Congestive heart failure
- Use of thiazolidinediones or exenatide
- currently suffering from depression, with or without treatment
- history of severe depression in the past which needed hospitalization
- currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
- Coronary event or procedure in the previous 6 months
- Hepatic disease (transaminase > 3 times normal) or cirrhosis
- Renal impairment (serum creatinine > 1.5)
- HIV or Hepatitis C positive status
- Participation in any other concurrent clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Millard Fillmore Gates Hospital
Buffalo, New York, 14209
About this study
Official title: Effect of Hypogonadotropic Hypogonadism and Replacement With Clomiphene Citrate and Testosterone on Insulin Sensitivity, Body Composition, Inflammation, Sexual Function and Spermatogenesis in Young Type 2 Diabetic Men
Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this grant, the investigators propose to study the effects of having low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat and muscle mass at specific areas of the body 3) expression of mediators of inflammation in the blood 4) semen quality. This study will compare diabetic men (with or without hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug that increases testosterone and sperm production) or testosterone in men with diabetes and hypogonadism. The investigators hope that this project will help us understand the state of hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us insights into treatment of this condition. With the rising prevalence of type 2 diabetes in the young, this project may have implications for public health.
Read the detailed description
This project will study young men with type 2 diabetes. We have shown that half of these men have low testosterone levels. This can lead to 1) Low muscle mass; 2) more fat mass; 3) insulin resistance; 4) low sperm count and 5) increased inflammation (that increases the risk of heart disease). This project will study these consequences in detail and also the possibility of reversing them with treatment. Information from this project will be useful in planning of future studies that will evaluate the effect of treatment of low testosterone on mortality, heart disease and stroke.
- Conditions
- Hypogonadotropic Hypogonadism, Type 2 Diabetes
- Being tested
- testosterone, clomiphene, placebo
- Keywords
- hypogonadism, diabetes, spermatogenesis, insulin resistance
- Medical subject headings
- Hypogonadism, Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosteroneDrug
intramuscular every 2 weeks
clomipheneDrug
thrice a week
placeboDrug
intramuscular saline injections every 2 weeks
placeboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| testosterone | Experimental | intramuscular injections every 2 weeks Receives: Drug: testosterone |
| clomiphene | Experimental | oral drug thrice a week Receives: Drug: clomiphene |
| placebo for testosterone | Placebo comparator | placebo for testosterone arm Receives: Drug: placebo |
| placebo for clomiphene | Placebo comparator | oral placebo for clomiphene arm Receives: Drug: placebo |
| eugonadal obese | No intervention | obese men with normal testosterone level |
| lean | No intervention | healthy lean men (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance
To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: lack of funding
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 Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, sandeep dhindsa, State University of New York at Buffalo
- Investigators
- Sandeep Dhindsa, MBBS, Principal investigator, SUNY at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155518
- Sponsor's protocol ID
- 1-10-JF-13
- Status last verified
- Oct 2019
- First submitted
- 30 Jun 2010
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypogonadotropic Hypogonadism and Replacement With Clomiphene Citrate and Testosterone on Insulin Sensitivity, Body Composition, Inflammation, Sexual Function and Spermatogenesis in Young Type 2 Diabetic Men
- ClinicalTrials.gov ID
- NCT01155518
- Acronym / sponsor ID
- 1-10-JF-13
- Conditions
- Hypogonadotropic Hypogonadism, Type 2 Diabetes
- Keywords
- hypogonadism, diabetes, spermatogenesis, insulin resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jun 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this grant, the investigators propose to study the effects of having low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat and muscle mass at specific areas of the body 3) expression of mediators of inflammation in the blood 4) semen quality. This study will compare diabetic men (with or without hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug that increases testosterone and sperm production) or testosterone in men with diabetes and hypogonadism. The investigators hope that this project will help us understand the state of hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us insights into treatment of this condition. With the rising prevalence of type 2 diabetes in the young, this project may have implications for public health.
Detailed description
This project will study young men with type 2 diabetes. We have shown that half of these men have low testosterone levels. This can lead to 1) Low muscle mass; 2) more fat mass; 3) insulin resistance; 4) low sperm count and 5) increased inflammation (that increases the risk of heart disease). This project will study these consequences in detail and also the possibility of reversing them with treatment. Information from this project will be useful in planning of future studies that will evaluate the effect of treatment of low testosterone on mortality, heart disease and stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| testosterone | Experimental | Drug: testosteroneintramuscular injections every 2 weeks |
| clomiphene | Experimental | Drug: clomipheneoral drug thrice a week |
| placebo for testosterone | Placebo comparator | Drug: placeboplacebo for testosterone arm |
| placebo for clomiphene | Placebo comparator | Drug: placebooral placebo for clomiphene arm |
| eugonadal obese | No intervention | –obese men with normal testosterone level |
| lean | No intervention | –healthy lean men (control) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- T2D Males with age 18-40 years
Key exclusion criteria (16 listed)
- planning to have children in the next one year
- Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
- PSA > 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
- Hemoglobin A1c > 8%
- Hematocrit > 50%
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 |
|---|---|---|
| testosteroneintramuscular every 2 weeks | Drug | testosterone |
| clomiphenethrice a week | Drug | clomiphene |
| placebointramuscular saline injections every 2 weeks | Drug | placebo for testosterone |
| placebooral | Drug | placebo for clomiphene |
Primary outcome
Insulin Resistance
Time frame: 6 months
To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- 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.
Sandeep Dhindsa, MBBS principal investigator
SUNY at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing testosterone and clomiphene in people with Hypogonadotropic Hypogonadism and Type 2 Diabetes, run by State University of New York 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 1 inclusion and 16 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: stopped early, as of the sponsor's last update on 4 Oct 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Oct 2019). 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?
Insulin Resistance (time frame: 6 months). 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 4 Oct 2019.