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OpenTrials
Completed

NCT Number: NCT01665716

Ovarian Ageing in Type 1 Diabetes Mellitus

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. OVADIA 1: serum AMH level

    Time frame: Blood withdrawel once at screening

  2. OVADIA 2: Age at menopause

    Time frame: Assesed once in questionnaire

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Ovarian Ageing in Type 1 Diabetes Mellitus: the Role of Vascular Factors

Acronym: OVADIA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 15, 2012
Registry last updated
Apr 11, 2014

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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