To evaluate the prevalence of advanced ovarian ageing in cycling DM-1 patients using ovarian reserve (OR) testing. To assess the mean age at natural menopause and its variation in DM-1 patients. To study the role of vascular factors in relation to…
ID
Source
Brief title
Condition
- Diabetic complications
- Menopause related conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part I:
1. Age specific AMH level
2. Number of antral follicles present in the ovaries
3. Vascular status using the ENDOVAS screening.
Part II:
1. Age in years at natural menopause assesed by means of questionnaires
Secondary outcome
Part I:
1. Metabolic status
2. Factors associated with early menopause: common genetic variants and
auto-immune factors
Part II:
1. Metabolic status if present in patient records.
Background 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.
Study objective
To evaluate the prevalence of advanced ovarian ageing in cycling DM-1 patients
using ovarian reserve (OR) testing.
To assess the mean age at natural menopause and its variation in DM-1 patients.
To study the role of vascular factors in relation to ovarian reserve status in
DM-1 cases.
In order to investigate these objectives this study consists of two seperate
parts. Part I consists of 150 premenopausal women and 20 healthy age-matched
female controles. Part II includes 140 postmenopausal women.
Study design
Part I and II: patient-control study
Study burden and risks
Part I:
The burden associated with participating in the study will be mostly
originating from blood sampling, non-invasive measurement of vascular
parameters (duration approximately one hour) and a transvaginal ultrasound.
There are no risks related to these investigations. Participating in the study
may be of benefit to the DM-1 women since they will be screened thoroughly for
vascular disease and ovarian reserve status and may receive medical advice
based on these clinical findings.
Part II: no risks, the burden consists of completing a questionnaire.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32242.041.10 |