NCT01665716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

2.7 years

First QC Date

August 13, 2012

Last Update Submit

April 10, 2014

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • OVADIA 1: serum AMH level

    Blood withdrawel once at screening

  • OVADIA 2: Age at menopause

    Assesed once in questionnaire

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients: females diagnosed with type 1 diabetes mellitus
  • Controls: healthy age-matched female controls

You may not qualify if:

  • Induced menopause: surgical (premenopausal hysterectomy and/or bilateral ovariectomy), chemo- or radiation therapy, ovarian surgery and irregular menstrual cycles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3508 GA, Netherlands

Location

Related Publications (2)

  • de Kat AC, Gremmels H, Verhaar MC, Broekmans FJ, Yarde F. Early Vascular Damage in Young Women with DM-1 and Its Relation to Anti-Mullerian Hormone: A Cross-Sectional Study. Int J Endocrinol. 2016;2016:1487051. doi: 10.1155/2016/1487051. Epub 2016 Aug 29.

    PMID: 27651793DERIVED

  • Yarde F, van der Schouw YT, de Valk HW, Franx A, Eijkemans MJ, Spiering W, Broekmans FJ; OVADIA study group. Age at menopause in women with type 1 diabetes mellitus: the OVADIA study. Hum Reprod. 2015 Feb;30(2):441-6. doi: 10.1093/humrep/deu327. Epub 2014 Dec 1.

    PMID: 25452435DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Frank Broekmans, MD, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. F. J. M. Broekmans

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 15, 2012

Study Start

July 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations

NL(1)