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ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
- Gonadotrophin and sex hormone changes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measruement of visceral fatvolume in women with PCOS and healthy controls
Relation between fatmass and ovarian volume
Relation between fatmass and adrenal volume
Relation fatmass and waist-hip-ratio
This is an exploratory study, so formal power calculations can not be made.
Differences between groups will be evaluated by comparison of mean and 95%
confidence interval. Also possible differences in metabolic and hormonal
parameters are assessed in this way.
Secondary outcome
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Background summary
Polycystic Ovary Syndrome is a heterogenous disease including polycystic
ovaries, anovulation and/or clinical or biochemical androgen excess. Lean as
well as obese PCOS patients are known with visceral fat deposition. Visceral
fat deposition and/or adrenal hyperplasia result in the clinical features as
observed in PCOS. Sensitivity of techniques estimating body fat distribution
used so far is poor en results are difficult to reproduce. Magnetic Resonance
technique is a reliable technique to determine body fat distribution and
results are easily reproduced without using X-ray. Evidence of visceral fat
accumulation as well as additional information determined by bloodsamples and
measurement of adrenal volume in lean PCOS patients may result in alternative
therapies.
Study objective
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Study design
Measurements
1. Waist hip circumference, skin fold thickness ( biceps, triceps, suprailiacal
(SI), subscapular (SS) and upper legs)
2. In the follicular phase :
fasting levels of glucose, insulin, C-peptide, cortisol,
androstendion,Testosteron, SHBG, FTI, DHEAS, Prolactin, TSH, freeT4, freeT3,
FSH, LH, estradiol, progesteron,17-OH-progesteron, serum and plasma
Adipokines (adiponectin, leptin, resistin), TNF-alpha, IL-6, IL-10 and
beta-endorphin.
3. intraabdominal and s.c. fat measurements as well as volume estimation of
adrenals and ovaries
Study burden and risks
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Geerdinksweg 141
7550 AM Hengelo
Nederland
Geerdinksweg 141
7550 AM Hengelo
Nederland
Listed location countries
Age
Inclusion criteria
patients with normal body weight and PCOS
Exclusion criteria
other endocrine diseases
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 | NL19035.042.07 |