type1diabetesNCT04950634
Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
An observational study of type1diabetes, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
Sex might interact with cardioautonomic neuropathy (CAN) in the development of macrovascular disease in patients with type 1 diabetes (T1D). The regulation of the autonomic system shows sexual dimorphism, and may contribute to the cardiovascular risk overload in women with T1D. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- type1diabetes
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to 1 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are selected from a consecutive cohort of individuals with T1D, who are regularly attending the outpatient clinic of the Diabetes Unit from Hospital Universitario Ramón y Cajal of Madrid.
Who may be able to join
- Diagnosis of type 1 diabetes mellitus, as defined by ADA criteria
Who cannot join
- Renal transplantation or renal replacement therapy;
- prior diagnosis of macrovascular disease (CHD, cerebrovascular disease, carotid disease, PAD, or atherosclerotic aortic aneurism);
- ongoing pregnancy;
- diagnosis of types of diabetes mellitus other than type 1;
- diagnosis of types of neuropathy other than diabetic neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sexual Dimorphism in the Prevalence and Progression of Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Sex might interact with cardioautonomic neuropathy (CAN) in the development of macrovascular disease in patients with type 1 diabetes (T1D). The regulation of the autonomic system shows sexual dimorphism, and may contribute to the cardiovascular risk overload in women with T1D.
The aims of this project are:
Read more
A.1) Determining the prevalence of CAN and subclinical atherosclerosis in a large cohort of consecutive patients with T1D as a function of sex (cross-sectional study).
A.2.) Addressing the progression of CAN and subclinical atherosclerosis in patients with T1D as a function of sex (longitudinal prospective study).
A.3.) Investigating the influence of sex steroids and circulating biomarkers in the development and progression of CAN and subclinical atherosclerosis.
Research designs:
A cross-sectional design/prevalence screening study determining the prevalence of CAN as a function of sex in 320 consecutive individuals with DM1.
A longitudinal prospective study: the cohort of prevalence screening study will be prospectively followed, and the assessment of cardiovascular autonomic function and subclinical atherosclerosis will be repeated over time.
- Conditions
- type1diabetes
- Keywords
- cardioautonomic neuropathy, sexual dimorphism, subclinical atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
To address sexual dimorphism in the prevalence of CAN in patients with T1D.
Blood pressure (mmHg) to active standing and Ewing and Clarke tests.
Measured: Two years
To address sexual dimorphism in the prevalence of CAN in patients with T1D.
Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
Measured: Two years
To address sexual dimorphism in subclinical atherosclerosis in patients with T1D.
Mean carotid intima-media thickness (mm)
Measured: Two years
To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.
Blood pressure (mmHg) to active standing and Ewing and Clarke tests.
Measured: Four years
To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.
Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
Measured: Four years
To assess the role of sex on the progression of subclinical atherosclerosis in patients with T1D.
Mean carotid intima-media thickness (mm)
Measured: Four years
Secondary outcomes (6)
To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.
Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
Measured: Four years
To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.
Blood pressure (mmHg) to active standing and Ewing and Clarke tests.
Measured: Four years
To identify the influence of sex steroids on the evolution of subclinical atherosclerosis
Mean carotid intima-media thickness (mm)
Measured: Four years
To identify novel circulating markers of CAN
Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
Measured: Four years
To identify novel circulating markers of CAN
Blood pressure (mmHg) to active standing and Ewing and Clarke tests.
Measured: Four years
To identify novel circulating markers of subclinical atherosclerosis
Mean carotid intima-media thickness (mm)
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Sep 2018
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for type1diabetesStudies 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
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950634
- Sponsor's protocol ID
- 189/17
- Status last verified
- Aug 2025
- First submitted
- 30 May 2021
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nattero-Chavez L, Insenser M, Amigo N, Samino S, Martinez-Micaelo N, Dorado Avendano B, Quintero Tobar A, Escobar-Morreale HF, Luque-Ramirez M. Quantification of lipoproteins by proton nuclear magnetic resonance spectroscopy (1H-NMRS) improves the prediction of cardiac autonomic dysfunction in patients with type 1 diabetes. J Endocrinol Invest. 2024 Aug;47(8):2075-2085. doi: 10.1007/s40618-023-02289-9. Epub 2024 Jan 6.
PubMed 38182920Insenser MR, Nattero-Chavez L, Luque-Ramirez M, Quinones SL, Quintero-Tobar A, Samino S, Amigo N, Dorado Avendano B, Fiers T, Escobar-Morreale HF. Investigating the Link between Intermediate Metabolism, Sexual Dimorphism, and Cardiac Autonomic Dysfunction in Patients with Type 1 Diabetes. Metabolites. 2024 Aug 6;14(8):436. doi: 10.3390/metabo14080436.
PubMed 39195532Nattero-Chavez L, Insenser M, Quintero Tobar A, Fernandez-Duran E, Dorado Avendano B, Fiers T, Kaufman JM, Luque-Ramirez M, Escobar-Morreale HF. Sex differences and sex steroids influence on the presentation and severity of cardiovascular autonomic neuropathy of patients with type 1 diabetes. Cardiovasc Diabetol. 2023 Feb 15;22(1):32. doi: 10.1186/s12933-023-01766-y.
PubMed 36793089Nattero-Chavez L, Alonso Diaz S, Jimenez-Mendiguchia L, Garcia-Cano A, Fernandez-Duran E, Dorado Avendano B, Escobar-Morreale HF, Luque-Ramirez M. Sexual Dimorphism and Sex Steroids Influence Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes. Diabetes Care. 2019 Nov;42(11):e175-e178. doi: 10.2337/dc19-1375. Epub 2019 Sep 17. No abstract available.
PubMed 31530659
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dimorphism in the Prevalence and Progression of Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04950634
- Acronym / sponsor ID
- 189/17
- Conditions
- type1diabetes
- Keywords
- cardioautonomic neuropathy, sexual dimorphism, subclinical atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 6 Jul 2021 (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.
Sex might interact with cardioautonomic neuropathy (CAN) in the development of macrovascular disease in patients with type 1 diabetes (T1D). The regulation of the autonomic system shows sexual dimorphism, and may contribute to the cardiovascular risk overload in women with T1D.
The aims of this project are:
A.1) Determining the prevalence of CAN and subclinical atherosclerosis in a large cohort of consecutive patients with T1D as a function of sex (cross-sectional study).
A.2.) Addressing the progression of CAN and subclinical atherosclerosis in patients with T1D as a function of sex (longitudinal prospective study).
A.3.) Investigating the influence of sex steroids and circulating biomarkers in the development and progression of CAN and subclinical atherosclerosis.
Research designs:
A cross-sectional design/prevalence screening study determining the prevalence of CAN as a function of sex in 320 consecutive individuals with DM1.
A longitudinal prospective study: the cohort of prevalence screening study will be prospectively followed, and the assessment of cardiovascular autonomic function and subclinical atherosclerosis will be repeated over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are selected from a consecutive cohort of individuals with T1D, who are regularly attending the outpatient clinic of the Diabetes Unit from Hospital Universitario Ramón y Cajal of Madrid.
Key inclusion criteria (1 listed)
- Diagnosis of type 1 diabetes mellitus, as defined by ADA criteria
Key exclusion criteria (5 listed)
- Renal transplantation or renal replacement therapy;
- prior diagnosis of macrovascular disease (CHD, cerebrovascular disease, carotid disease, PAD, or atherosclerotic aortic aneurism);
- ongoing pregnancy;
- diagnosis of types of diabetes mellitus other than type 1;
- diagnosis of types of neuropathy other than diabetic neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To address sexual dimorphism in the prevalence of CAN in patients with T1D.
Time frame: Two years
Blood pressure (mmHg) to active standing and Ewing and Clarke tests.
To address sexual dimorphism in the prevalence of CAN in patients with T1D.
Time frame: Two years
Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
To address sexual dimorphism in subclinical atherosclerosis in patients with T1D.
Time frame: Two years
Mean carotid intima-media thickness (mm)
To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.
Time frame: Four years
Blood pressure (mmHg) to active standing and Ewing and Clarke tests.
To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.
Time frame: Four years
Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
To assess the role of sex on the progression of subclinical atherosclerosis in patients with T1D.
Time frame: Four years
Mean carotid intima-media thickness (mm)
6 secondary outcomes
To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.
Time frame: Four years
To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.
Time frame: Four years
To identify the influence of sex steroids on the evolution of subclinical atherosclerosis
Time frame: Four years
To identify novel circulating markers of CAN
Time frame: Four years
To identify novel circulating markers of CAN
Time frame: Four years
To identify novel circulating markers of subclinical atherosclerosis
Time frame: Four years
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 7 Aug 2025.
- Results publication: PubMed 38182920Nattero-Chavez L, Insenser M, Amigo N, Samino S, Martinez-Micaelo N, Dorado Avendano B, Quintero Tobar A, Escobar-Morreale HF, Luque-Ramirez M. Quantification of lipoproteins by proton nuclear magnetic resonance spectroscopy (1H-NMRS) improves the prediction of cardiac autonomic dysfunction in patients with type 1 diabetes. J Endocrinol Invest. 2024 Aug;47(8):2075-2085. doi: 10.1007/s40618-023-02289-9. Epub 2024 Jan 6.
- Results publication: PubMed 39195532Insenser MR, Nattero-Chavez L, Luque-Ramirez M, Quinones SL, Quintero-Tobar A, Samino S, Amigo N, Dorado Avendano B, Fiers T, Escobar-Morreale HF. Investigating the Link between Intermediate Metabolism, Sexual Dimorphism, and Cardiac Autonomic Dysfunction in Patients with Type 1 Diabetes. Metabolites. 2024 Aug 6;14(8):436. doi: 10.3390/metabo14080436.
- Results publication: PubMed 36793089Nattero-Chavez L, Insenser M, Quintero Tobar A, Fernandez-Duran E, Dorado Avendano B, Fiers T, Kaufman JM, Luque-Ramirez M, Escobar-Morreale HF. Sex differences and sex steroids influence on the presentation and severity of cardiovascular autonomic neuropathy of patients with type 1 diabetes. Cardiovasc Diabetol. 2023 Feb 15;22(1):32. doi: 10.1186/s12933-023-01766-y.
- Results publication: PubMed 31530659Nattero-Chavez L, Alonso Diaz S, Jimenez-Mendiguchia L, Garcia-Cano A, Fernandez-Duran E, Dorado Avendano B, Escobar-Morreale HF, Luque-Ramirez M. Sexual Dimorphism and Sex Steroids Influence Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes. Diabetes Care. 2019 Nov;42(11):e175-e178. doi: 10.2337/dc19-1375. Epub 2019 Sep 17. No abstract available.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of type1diabetes, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 5 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 7 Aug 2025. 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 Spain. 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?
To address sexual dimorphism in the prevalence of CAN in patients with T1D. (time frame: Two years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04950634, which also lists 4 linked publications.
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 7 Aug 2025.