We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04950634
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

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.


Condition or disease
type1diabetes

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sexual Dimorphism in the Prevalence and Progression of Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. To address sexual dimorphism in subclinical atherosclerosis in patients with T1D. [ Time Frame: Two years ]
    Mean carotid intima-media thickness (mm)

  4. 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.

  5. 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.

  6. 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)


Secondary Outcome Measures :
  1. To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction. [ Time Frame: Four years ]
    Heart rate responses (bpm) to active standing and Ewing and Clarke tests.

  2. To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction. [ Time Frame: Four years ]
    Blood pressure (mmHg) to active standing and Ewing and Clarke tests.

  3. To identify the influence of sex steroids on the evolution of subclinical atherosclerosis [ Time Frame: Four years ]
    Mean carotid intima-media thickness (mm)

  4. To identify novel circulating markers of CAN [ Time Frame: Four years ]
    Heart rate responses (bpm) to active standing and Ewing and Clarke tests.

  5. To identify novel circulating markers of CAN [ Time Frame: Four years ]
    Blood pressure (mmHg) to active standing and Ewing and Clarke tests.

  6. To identify novel circulating markers of subclinical atherosclerosis [ Time Frame: Four years ]
    Mean carotid intima-media thickness (mm)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

- Diagnosis of type 1 diabetes mellitus, as defined by ADA criteria

Exclusion Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04950634


Contacts
Layout table for location contacts
Contact: Lía Nattero Chávez, MD PhD +34913369029 marialia.nattero@salud.madrid.org
Contact: Manuel Luque-Ramírez, MD PhD +34913369029 manuel.luque@salud.madrid.org

Locations
Layout table for location information
Spain
Lía Nattero Chávez Recruiting
Madrid, Spain, 28034
Contact: Lía Nattero Chávez, MD PhD    +34913369029    marialia.nattero@salud.madrid.org   
Contact: Manuel Luque-Ramírez, MD PhD    +34913369029    manuel.luque@salud.madrid.org   
Principal Investigator: Lía Nattero-Chávez, MD PhD         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT04950634    
Other Study ID Numbers: 189/17
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
cardioautonomic neuropathy
sexual dimorphism
subclinical atherosclerosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases