Ovarian Ageing in Type 1 Diabetes Mellitus | NCT01665716

Studies
Ovarian Ageing in Type 1 Diabetes Mellitus

NCT01665716

Sponsor

UMC Utrecht

Status

Completed

Last Update Posted

Apr 11, 2014Estimated

Enrollment

290Actual

Phase

Not provided

Conditions

Type 1 Diabetes Mellitus

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
10-345	Other Identifier	Medical Ethics Committee UMC Utrecht

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Aug 13, 2012

First Submission Date that Met QC Criteria

Aug 13, 2012

First Posted Date

Aug 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2014

Last Update Posted Date

Apr 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

290Actual

Measure	Description	Time Frame
OVADIA 1: serum AMH level		Blood withdrawel once at screening
OVADIA 2: Age at menopause		Assesed once in questionnaire

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Frank Broekmans, MD, PhD	UMC Utrecht	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Utrecht		Utrecht	Utrecht	3508 GA	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27651793	Derived	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.
25452435	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases