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

NCT03573063 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-09-06

No results posted yet for this study

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.

Conditions

  • PCOS Disease

Interventions

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.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Christa Flück · Pädiatrische Endokrinologie, Inselspital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-26
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03573063 on ClinicalTrials.gov