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Completed

NCT Number: NCT04950634

Sexual Dimorphism in 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:

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.

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Key information

Conditions

Type1diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lía Nattero Chávez

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

Sexual Dimorphism in the Prevalence and Progression of Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2021
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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