Hypogonadism, MalePhase 4SETH2NCT03792321
Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)
A Phase 4 study testing Testosterone Undecanoate in people with Hypogonadism, Male and Diabetes Mellitus, Type 2, run by University Medical Centre Ljubljana.
Trial summary
Aim of the study was to investigate the effects of testosterone replacement therapy on components of metabolic syndrome, vascular function and morphology, grade of non-alcoholic fatty liver disease (NAFLD), bone mineral density (BMD) and health-related quality of life. Read more about this study
- Who is it for?
- Ages 35 years and older, men only
- Conditions the study is for
- Hypogonadism, Male, Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Testosterone Undecanoate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2014to 5 Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men aged > 35 years
- body mass index > 30 kg/m2
- confirmed hypogonadism
- type 2 diabetes mellitus treated with non-insulin therapy
Who cannot join
- previously treated hypogonadism
- the 2 diabetes mellitus treated with insulin therapy
- a history of current prostate or breast cancer
- severe benign prostatic hyperplasia
- elevated prostate-specific antigen (PSA > 4.0 lg/l)
- severe heart failure
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- acute coronary event or procedure during the six months leading up to the study
- chronic obstructive lung disease
- hypothyroidism
- severe obstructive sleep apnea (OSA)
- active infection
- rheumatoid arthritis
About this study
Official title: Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2
Aim of the study was to investigate the effects of testosterone replacement therapy on components of metabolic syndrome, vascular function and morphology, grade of non-alcoholic fatty liver disease (NAFLD), bone mineral density (BMD) and health-related quality of life.
Read the detailed description
Studies have shown that approximately 50 % of older obese males, who are being treated for diabetes mellitus type 2, also exhibit low testosterone levels. Hypogonadism negatively affects glycemic control, exacerbates early cardio-vascular disease, causes osteoporosis, erectile disfunction, reduces lean body mass, accelerates the accumulation of visceral fat and leads to obesity.
Patients with diabetes mellitus type 2 and confirmed hypogonadism were enrolled into this randomized, double-blind, placebo-controlled clinical study. Placebo group patients were receiving placebo throughout the first year of this study and Testosterone group patients were receiving testosterone undecanoate during first year. Both groups were receiving testosterone undecanoate throughout the second year of this study.
- Conditions
- Hypogonadism, Male, Diabetes Mellitus, Type 2, Obesity
- Being tested
- Testosterone Undecanoate, Placebo
- Keywords
- testosterone, hypogonadism, diabetes mellitus, visceral obesity, insulin resistance, metabolic syndrome, NAFLD, endothelial function
- Medical subject headings
- Eunuchism, Diabetes Mellitus, Type 2, Obesity, Hypogonadism, Diabetes Mellitus, Obesity, Abdominal, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone UndecanoateDrug
Also called Nebido
1000 mg i.m. every 10 weeks
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Active comparator | Testosterone arm patients were receiving testosterone undecanoate 1000 mg intramuscular injections two years; according to the protocol every 10 weeks Receives: Drug: Testosterone Undecanoate |
| Placebo | Placebo comparator | Placebo arm patients were receiving placebo throughout the first year of this study and testosterone undecanoate 1000 mg intramuscular injections during second year. Receives: Drug: Testosterone Undecanoate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l
The primary outcome measure was change in glycemic control - fasting plasma glucose (FPG) mmol/l
Measured: FPG was measured at baseline, after 12 months and after 24 months
Effects of testosterone replacement therapy on glycemic control - glycated hemoglobin A1c (HbA1c) %
The primary outcome measure was change in glycemic control - glycated hemoglobin A1c (HbA1c) %
Measured: HbA1c was measured at baseline, after 12 months and after 24 months
Effects of testosterone replacement therapy on parameters of metabolic syndrome - change in HOMA-IR
The primary outcome measure was change in Homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: HOMA-IR was calculated at the baseline, after 12 months and after 24 months of clinical trial.
Effects of testosterone replacement therapy on vascular function - change in flow mediated dilatation (FMD) %
The primary outcome measure was change in flow mediated dilatation (FMD) % assessed by vascular ultrasound
Measured: FMD was measured at baseline, after 12 months and after 24 months
Effects of testosterone replacement therapy on vascular morphology - intima-media thickness (IMT)
The primary outcome measure was change in intima-media thickness (IMT) mm assessed by vascular ultrasound
Measured: IMT was measured at baseline, after 12 months and after 24 months
Secondary outcomes (5)
Effects of testosterone replacement therapy on non-alcoholic fatty liver disease (NAFLD)
The secondary outcome was change in grade of non-alcoholic fatty liver disease (NAFLD) graded as either "none", "mild", "moderate" and "severe", assessed by abdominal ultrasound
Measured: Grade of NAFLD was determined at baseline and after 24 months
Effects of testosterone replacement therapy on bone mineral density (BMD)
The secondary outcome was change in bone mineral density assessed by dual-energy x-ray absorptiometry (DXA) g/cm^2
Measured: Change in bone mineral density was measured at baseline and after 24 months
Effects of testosterone replacement on total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations
The secondary outcome were changes in total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations - all in nmol/l
Measured: Changes in total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations were measured baseline, after 12 months and 24 months
Effects of testosterone replacement on prostate specific antigen (PSA)
The secondary outcome was change in prostate specific antigen (PSA) ng/ml
Measured: Prostate specific antigen (PSA) was measured at baseline,3,6,12,15,18 and 24 months
Effects of testosterone replacement on hematocrit
The secondary outcome was change in hematocrit (Hct) %
Measured: Hematocrit was measured at baseline,3,6,12,15,18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start10 Jan 2014
- Primary completion5 Mar 2015
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism, MaleStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 55 patients were divided in two groups. P group patients were receiving placebo throughout the first year of this study and T group patients were receiving testosterone. Both groups were receiving TRT throughout the second year.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Groti, University Medical Centre Ljubljana
- Investigators
- Kristina Groti Antonic, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792321
- Sponsor's protocol ID
- SBCE-KG-2014-1
- Acronym
- SETH2
- Status last verified
- Jan 2019
- First submitted
- 27 Dec 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2
- ClinicalTrials.gov ID
- NCT03792321
- Acronym / sponsor ID
- SETH2 / SBCE-KG-2014-1
- Conditions
- Hypogonadism, Male, Diabetes Mellitus, Type 2, Obesity
- Keywords
- testosterone, hypogonadism, diabetes mellitus, visceral obesity, insulin resistance, metabolic syndrome, NAFLD, endothelial function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- 5 Mar 2015 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study was to investigate the effects of testosterone replacement therapy on components of metabolic syndrome, vascular function and morphology, grade of non-alcoholic fatty liver disease (NAFLD), bone mineral density (BMD) and health-related quality of life.
Detailed description
Studies have shown that approximately 50 % of older obese males, who are being treated for diabetes mellitus type 2, also exhibit low testosterone levels. Hypogonadism negatively affects glycemic control, exacerbates early cardio-vascular disease, causes osteoporosis, erectile disfunction, reduces lean body mass, accelerates the accumulation of visceral fat and leads to obesity.
Patients with diabetes mellitus type 2 and confirmed hypogonadism were enrolled into this randomized, double-blind, placebo-controlled clinical study. Placebo group patients were receiving placebo throughout the first year of this study and Testosterone group patients were receiving testosterone undecanoate during first year. Both groups were receiving testosterone undecanoate throughout the second year of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 55 patients were divided in two groups. P group patients were receiving placebo throughout the first year of this study and T group patients were receiving testosterone. Both groups were receiving TRT throughout the second year.
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Active comparator | Drug: Testosterone UndecanoateTestosterone arm patients were receiving testosterone undecanoate 1000 mg intramuscular injections two years; according to the protocol every 10 weeks |
| Placebo | Placebo comparator | Drug: Testosterone Undecanoate, Drug: PlaceboPlacebo arm patients were receiving placebo throughout the first year of this study and testosterone undecanoate 1000 mg intramuscular injections during second year. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men aged > 35 years
- body mass index > 30 kg/m2
- confirmed hypogonadism
- type 2 diabetes mellitus treated with non-insulin therapy
Key exclusion criteria (12 listed)
- previously treated hypogonadism
- the 2 diabetes mellitus treated with insulin therapy
- a history of current prostate or breast cancer
- severe benign prostatic hyperplasia
- elevated prostate-specific antigen (PSA > 4.0 lg/l)
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 |
|---|---|---|
| Testosterone UndecanoateAlso: Nebido1000 mg i.m. every 10 weeks | Drug | Placebo, Testosterone |
| Placebo | Drug | Placebo |
Primary outcome
Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l
Time frame: FPG was measured at baseline, after 12 months and after 24 months
The primary outcome measure was change in glycemic control - fasting plasma glucose (FPG) mmol/l
Effects of testosterone replacement therapy on glycemic control - glycated hemoglobin A1c (HbA1c) %
Time frame: HbA1c was measured at baseline, after 12 months and after 24 months
The primary outcome measure was change in glycemic control - glycated hemoglobin A1c (HbA1c) %
Effects of testosterone replacement therapy on parameters of metabolic syndrome - change in HOMA-IR
Time frame: HOMA-IR was calculated at the baseline, after 12 months and after 24 months of clinical trial.
The primary outcome measure was change in Homeostasis model assessment of insulin resistance (HOMA-IR)
Effects of testosterone replacement therapy on vascular function - change in flow mediated dilatation (FMD) %
Time frame: FMD was measured at baseline, after 12 months and after 24 months
The primary outcome measure was change in flow mediated dilatation (FMD) % assessed by vascular ultrasound
Effects of testosterone replacement therapy on vascular morphology - intima-media thickness (IMT)
Time frame: IMT was measured at baseline, after 12 months and after 24 months
The primary outcome measure was change in intima-media thickness (IMT) mm assessed by vascular ultrasound
5 secondary outcomes
Effects of testosterone replacement therapy on non-alcoholic fatty liver disease (NAFLD)
Time frame: Grade of NAFLD was determined at baseline and after 24 months
Effects of testosterone replacement therapy on bone mineral density (BMD)
Time frame: Change in bone mineral density was measured at baseline and after 24 months
Effects of testosterone replacement on total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations
Time frame: Changes in total testosterone (TT), calculated free testosterone (cFT), and calculated bioavailable testosterone (BT) concentrations were measured baseline, after 12 months and 24 months
Effects of testosterone replacement on prostate specific antigen (PSA)
Time frame: Prostate specific antigen (PSA) was measured at baseline,3,6,12,15,18 and 24 months
Effects of testosterone replacement on hematocrit
Time frame: Hematocrit was measured at baseline,3,6,12,15,18 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Kristina Groti Antonic, MD, PhD principal investigator
University Medical Centre Ljubljana
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone Undecanoate in people with Hypogonadism, Male and Diabetes Mellitus, Type 2, run by University Medical Centre Ljubljana.
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 4 inclusion and 12 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 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l (time frame: FPG was measured at baseline, after 12 months and after 24 months). The study lists 5 primary outcomes in all. 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 Jan 2019.