Ovarian Ageing in Type 1 Diabetes Mellitus

NCT ID: NCT01665716

Last Updated: 2014-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Frank JM Broekmans

Prof. Dr. F. J. M. Broekmans

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank Broekmans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 27651793 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25452435 (View on PubMed)

Other Identifiers

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10-345

Identifier Type: OTHER

Identifier Source: secondary_id

NL32242.041.10

Identifier Type: -

Identifier Source: org_study_id

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