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Trial record 3 of 1543 for:    Androgens

Studying the Starvation Effect on Androgen Metabolism in 20 Healthy Young Women and Comparison to Women With PCOS. (SEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03573063
Recruitment Status : Completed
First Posted : June 29, 2018
Last Update Posted : September 6, 2019
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

In this study, the investigators wanted to investigate the energy homeostasis and the steroid metabolism of 20 healthy, young and normal weight women aged between 16-35 years before and after a 48 hours fasting period.

The following substrates and hormone concentrations representing the carbohydrate, fat and protein metabolism will be measured from plasma or urine before and after fasting: glucose, insulin, lactate, alpha-synucleine, free fatty acids, beta-hydroxybutyrate (ketone bodies), carnitine (surrogate for acetyl-CoA) and alanine (amino acids). In addition, the investigators will measure 67 steroid metabolites by GC/MS and Biokrates AbsolutIDQ Steroid Assay in all collected urines and blood samples.

In the analysis of the data, the investigators will focus on correlations between biochemical parameters of the energy metabolism and parameters of the steroid metabolism, specifically the androgens. In addition, the steroid profiles obtained from healthy young women before and after fasting will be compared to steroid profiles of PCOS women in search for specific differences.

Condition or disease Intervention/treatment Phase
PCOS Disease Other: Androgen metabolism after starvation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Clinical study with biological sampling in healthy young women being nutrionally restricted (using encoded data)
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Starvation Effect on Androgen Metabolism in Healthy Young Women.
Actual Study Start Date : October 26, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Arm Intervention/treatment
Androgen metabolism after starvation
Metabolism changes after 48 hours starvation in healthy women
Other: Androgen metabolism after starvation

The 20 women will all undergo the same process of starvation for 48 hours. During this time three blood samples and three 24-hours urine samples will be collected. At baseline, the investigators will draw blood, perform a pregnancy test and collect the 24 hours urine as well as a spot urine.

Then the 48 hours starvation starts and two blood and two 24 hours urine samples and spot urines will be collected after 24 and 48 hours in the morning. After the third visit the study is completed for the participant.

Primary Outcome Measures :
  1. The primary outcome is changes in androgen metabolism. The evaluation will compare the steroid concentrations at the three time points with uni- and multivariate data analysis to detect fasting-related differences. [ Time Frame: One year ]
    With GC/MS (urine) and LCMSMS (blood) 40 steroids in urine (ug/24h) and 18 steroids in serum (pg/ml or nmol/L) (Biokrates) will be measured; these includes Progesterones, Androgens, Estrogens, Corticosterones, Mineralocorticoids, Glucocorticoids. Other markers consist of glucose (mmol/L), potassium (mmol/L), insulin (mU/L), lactate (mmol/L), free fatty acids (umol/L), ketone-bodies (beta-hydroxy-butyrate), carnitin, alanin - all umol/L). All parameters will be analysed in the laboratories of the Institute of Clinical Chemistry and Steroid Laboratory of Nephrology of Inselspital. For more details please see list in Appendices of the Clinical Study Protocol (Page 38-41). All data are assessed as absolute values and follow-up is studied for changes in values rather than for normative values, which mostly do not exist for fasting intervention.

Secondary Outcome Measures :
  1. Steroid profiles [ Time Frame: One year ]
    Working hypothesis: Starvation may change steroid profiles in similar direction as PCOS? - To test this hypothesis the collected biological samples of the participant will be analysed for steroid metabolic markers (see primary outcome measures) to same markers collected from a cohort of PCOS women available from a previous study for comparison.

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Aged 16-35
  • Normal weight
  • Healthy
  • Postpubertal
  • No drug treatments (including oral/hormonal anticonception)
  • Informed consent

Exclusion Criteria:

  • Hormone treatment (i.e.: hormonal contraception, cortisol)
  • Hormone disorders
  • Infertile
  • Anorexic
  • Obese
  • Pregnant
  • Chronic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03573063

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Benjamin P. Magyar
Aarau, Switzerland, 500
Sponsors and Collaborators
University Hospital Inselspital, Berne
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Principal Investigator: Christa Flück Pädiatrische Endokrinologie, Inselspital

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Responsible Party: University Hospital Inselspital, Berne Identifier: NCT03573063     History of Changes
Other Study ID Numbers: 2017-00982
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
healthy women
Additional relevant MeSH terms:
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Nutrition Disorders
Ascorbic Acid
Estrogens, Conjugated (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Growth Substances
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents