Diabete MellitusDIAPONCT05752591
Hypothalamic-pituitary Dysfunction in Diabetes
An observational study of Diabete Mellitus and Hypogonadism, run by Istituto Auxologico Italiano at 2 sites in Italy.
Trial summary
Type 2 Diabetes mellitus (T2DM) is a chronic disease with a high prevalence and several comorbidities impacting on public health and society. Among the complications of T2DM it has been showed a high prevalence of hypogonadotropic hypogonadism. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Diabete Mellitus, Hypogonadism, Hypogonadotropic Hypogonadism
- What is being tested?
- Diagnostic testing
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 25 May 2018to 14 Mar 2024
- Phase
- Observational
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Cross-sectional, observational study in T2DM patients (minimum 150). The inclusion will be through consecutive enrollment in diabetology clinics.
Who may be able to join
- age between 18 and 80 years old
- males
- proved diagnosis of T2DM
Who cannot join
- patients affected with known hypothalamic-pituitary diseases at the enrollment.
- patients affected with severe systemic diseases, fever, chronic inflammatory disorders with PCR > 10 mg/dL
- malnutrition with BMI <17 Kg/m2
- use of glucocorticoids at the enrollment
- poor understanding of spoken and written Italian
- patients affected with known primary diseases of the testes at the enrollment
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Istituto Auxologico Italiano
Milan, 20145
ASST Fatebenefratelli Sacco
Milan
About this study
Official title: Study of the Hypothalamic-pituitary Dysfuntion in Patients With Diabetes Mellitus
Type 2 Diabetes mellitus (T2DM) is a chronic disease with a high prevalence and several comorbidities impacting on public health and society. Among the complications of T2DM it has been showed a high prevalence of hypogonadotropic hypogonadism. Even if hypogonadism is associated to a worse metabolic profile and cardiovascular risk, it is discussed whether and when to treat this potentially reversible form associated to diabetes. In fact, the pathogenic mechanism of this condition in diabetic patients is not fully understood, and its clinical correlates, including the prevalence of other possible associated hypothalamic-pituitary axes dysfunctioning, questioned. The aim of the present study is to assess with an observational, cross sectional study on a large series of type 2 diabetic patients, enrolled consecutively: all the suspected etiologies of this complication in one single evaluation (both acquired and genetic congenital predisposition), its clinical correlates and the real prevalence of the disease using the lastly validated criteria for late onset hypogonadotropic hypogonadism.
- Conditions
- Diabete Mellitus, Hypogonadism, Hypogonadotropic Hypogonadism, Hypergonadotropic Hypogonadism, Central Hypothyroidism
- Being tested
- Diagnostic testing
- Medical subject headings
- Diabetes Mellitus, Hypogonadism, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testingDiagnostic test
Blood diagnostic testing for hypothalamic-pituitary-gonadal axis and hypothalamic-pituitary-thyroid axis. In case of gonadal or thyroid dysfunction, genetic testing for known implicated genes
| Study group | Role | What they receive |
|---|---|---|
| Enrolled patients with DM | Not described Receives: Diagnostic Test: Diagnostic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Hypogonadism
LH, FSH, Testosterone, Estradiol
Measured: baseline
Genetic predisposition
NGS analysis based on the analysis of a customized gene-panel with all known Congenital Hypogonadotropic Hypogonadism genes
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start25 May 2018
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Bonomi, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752591
- Sponsor's protocol ID
- 05C823
- Acronym
- DIAPO
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Hypothalamic-pituitary Dysfuntion in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05752591
- Acronym / sponsor ID
- DIAPO / 05C823
- Conditions
- Diabete Mellitus, Hypogonadism, Hypogonadotropic Hypogonadism, Hypergonadotropic Hypogonadism, Central Hypothyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 2 Mar 2023 (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.
Type 2 Diabetes mellitus (T2DM) is a chronic disease with a high prevalence and several comorbidities impacting on public health and society. Among the complications of T2DM it has been showed a high prevalence of hypogonadotropic hypogonadism. Even if hypogonadism is associated to a worse metabolic profile and cardiovascular risk, it is discussed whether and when to treat this potentially reversible form associated to diabetes. In fact, the pathogenic mechanism of this condition in diabetic patients is not fully understood, and its clinical correlates, including the prevalence of other possible associated hypothalamic-pituitary axes dysfunctioning, questioned. The aim of the present study is to assess with an observational, cross sectional study on a large series of type 2 diabetic patients, enrolled consecutively: all the suspected etiologies of this complication in one single evaluation (both acquired and genetic congenital predisposition), its clinical correlates and the real prevalence of the disease using the lastly validated criteria for late onset hypogonadotropic hypogonadism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled patients with DM | – | Diagnostic Test: Diagnostic testing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cross-sectional, observational study in T2DM patients (minimum 150). The inclusion will be through consecutive enrollment in diabetology clinics.
Key inclusion criteria (3 listed)
- age between 18 and 80 years old
- males
- proved diagnosis of T2DM
Key exclusion criteria (6 listed)
- patients affected with known hypothalamic-pituitary diseases at the enrollment.
- patients affected with severe systemic diseases, fever, chronic inflammatory disorders with PCR > 10 mg/dL
- malnutrition with BMI <17 Kg/m2
- use of glucocorticoids at the enrollment
- poor understanding of spoken and written Italian
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 |
|---|---|---|
| Diagnostic testingBlood diagnostic testing for hypothalamic-pituitary-gonadal axis and hypothalamic-pituitary-thyroid axis. In case of gonadal or thyroid dysfunction, genetic testing for known implicated genes | Diagnostic test | Enrolled patients with DM |
Primary outcome
Prevalence of Hypogonadism
Time frame: baseline
LH, FSH, Testosterone, Estradiol
Genetic predisposition
Time frame: baseline
NGS analysis based on the analysis of a customized gene-panel with all known Congenital Hypogonadotropic Hypogonadism genes
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 15 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Mellitus and Hypogonadism, run by Istituto Auxologico Italiano at 2 sites in Italy.
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 3 inclusion and 6 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Prevalence of Hypogonadism (time frame: baseline). The study lists 2 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 15 Mar 2024.