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Ovarian Ageing in Type 1 Diabetes Mellitus

Completed
Conditions
Type 1 Diabetes Mellitus
Registration Number
NCT01665716
Lead Sponsor
UMC Utrecht
Brief Summary

In healthy women, early menopause is an event that is associated with the exacerbation of several risk factors of cardiovascular and skeletal disease. The occurrence of an early menopause may have even greater impact in women with type 1 diabetes mellitus (DM-1). A small number of studies has demonstrated that DM-1 patients experience cycle irregularity and menopause at a younger age compared to controls. In addition, initial studies have suggested that also in regular cycling DM-1 women a decreased ovarian reserve status for age is present. The explanation for this early decay in ovarian reserve in DM-1 patients remains unknown. Next to auto immunity, vascular factors may be possible contributors to accelerated ovarian ageing in DM-1 patients.

Confirmation of more accelerated ovarian ageing in DM-1 women is urgently needed in view of the added risk factors outlined above. Also, the mechanisms behind the advanced ovarian ageing, with focus on vascular factors, may shed new light on our understanding of the ovarian ageing process per se.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
290
Inclusion Criteria
  • Patients: females diagnosed with type 1 diabetes mellitus
  • Controls: healthy age-matched female controls
Exclusion Criteria
  • Induced menopause: surgical (premenopausal hysterectomy and/or bilateral ovariectomy), chemo- or radiation therapy, ovarian surgery and irregular menstrual cycles.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
OVADIA 1: serum AMH levelBlood withdrawel once at screening
OVADIA 2: Age at menopauseAssesed once in questionnaire
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University Medical Center Utrecht

🇳🇱

Utrecht, Netherlands

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