Ovarian Ageing in Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

— OVADIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665716
• Other study ID #: NL32242.041.10
• Secondary ID: 10-345
• Status: Completed
• Phase: N/A
• First received: August 13, 2012
• Last updated: April 10, 2014
• Start date: July 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OVADIA 1: serum AMH level		Blood withdrawel once at screening	No
Primary	OVADIA 2: Age at menopause		Assesed once in questionnaire	No