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Type 1 Diabetes MellitusOVADIANCT01665716

Ovarian Ageing in Type 1 Diabetes Mellitus

An observational study of Type 1 Diabetes Mellitus, run by UMC Utrecht at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes Mellitus
How many people
290 participants
Where
1 siteNetherlands
Study dates
Jul 2011to Mar 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Utrecht

    Utrecht, Utrecht, 3508 GA

Other trials in Netherlands

About this study

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

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.

Medical subject headings
Diabetes Mellitus, Type 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OVADIA 1: serum AMH level

    Measured: Blood withdrawel once at screening

  2. OVADIA 2: Age at menopause

    Measured: Assesed once in questionnaire

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2012 (estimated)
  2. Study startJul 2011
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01665716
Sponsor's protocol ID
NL32242.041.10
Other IDs
10-345
Acronym
OVADIA
Status last verified
Apr 2014
First submitted
13 Aug 2012
Last updated
11 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27651793

  • 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.

    PubMed 25452435

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes Mellitus, run by UMC Utrecht at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OVADIA 1: serum AMH level (time frame: Blood withdrawel once at screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01665716, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2014.

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