Ovarian Ageing in Type 1 Diabetes Mellitus (OVADIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank JM Broekmans, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01665716
First received: August 13, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Ovarian Ageing in Type 1 Diabetes Mellitus: the Role of Vascular Factors

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • OVADIA 1: serum AMH level [ Time Frame: Blood withdrawel once at screening ] [ Designated as safety issue: No ]
  • OVADIA 2: Age at menopause [ Time Frame: Assesed once in questionnaire ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 290
Study Start Date: July 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Part I: Premenopausal women diagnosed with DM-1 older than 18 years and registered at the department for Endocrinology of in several Dutch hospitals.

Reference group: the Scheffer, Van Rooij, De Vet (SRV) cohort of normal fertile Caucasian women (n=250), recruited in the period of 1990 till 2000.

For the substudy concerning EPCs will we recruite a control group of 20 healthy female age-matched controls. We will recruite these women within the UMC Utrecht due to logistic reasons.

Part II: Postmenopausal women diagnosed with DM-1 and registered at the department for Endocrinology of several Dutch hospitals. Reference group:a selection of women from the Prospect-EPIC cohort, who had experienced natural menopause

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01665716

Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Frank Broekmans, MD, PhD UMC Utrecht
  More Information

No publications provided

Responsible Party: Frank JM Broekmans, Prof. Dr. F. J. M. Broekmans, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01665716     History of Changes
Other Study ID Numbers: NL32242.041.10, 10-345
Study First Received: August 13, 2012
Last Updated: April 10, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 14, 2014