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Clinical Trials/NCT03436992
NCT03436992
Completed
Not Applicable

Estrogen-Mediated Impairments of Vascular Health in Diabetes

Augusta University2 sites in 1 country143 target enrollmentApril 17, 2018
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ConditionsDiabetes Mellitus, Type 1

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 1
Sponsor
Augusta University
Enrollment
143
Locations
2
Primary Endpoint
FMD/Shear
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Diabetes has recently been referred to as "the epidemic of the 21st century". The reason why women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (CVD) compared to men with type 1 diabetes is unknown.The purpose of this study is to investigate whether or not estrogen contributes to vascular dysfunction in premenopausal women with diabetes.

Registry
clinicaltrials.gov
Start Date
April 17, 2018
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ryan Harris

Associate Professor

Augusta University

Eligibility Criteria

Inclusion Criteria

  • •Both men and premenopausal
  • •Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles
  • •All races
  • •Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)

Exclusion Criteria

  • •Clinical diagnosis of hepatic, cardiovascular, or renal disease
  • •Uncontrolled Diabetes (HbA1c\>9%)
  • •Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
  • •Proteinuria
  • •Uncontrolled Hypertension (\>140/90 mmHg on therapy)
  • •Hormonal use of birth control (past 3 months)
  • •Pregnancy
  • •Oligomenorrhea
  • •Direct vasoactive medications (i.e. nitrates)
  • •Anti-estrogens (i.e. SERMs)

Outcomes

Primary Outcomes

FMD/Shear

Time Frame: ~ 2 weeks. Acquired at Menses and Late Follicular phase.

Flow-Mediated Dilation (FMD) controlled for shear

Study Sites (2)

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