Comparison of two therapies for hyperandrogenism in girls

ISRCTN ISRCTN45546616
DOI https://doi.org/10.1186/ISRCTN45546616
Secondary identifying numbers PI09/90444
Submission date
15/01/2010
Registration date
06/04/2010
Last edited
08/07/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Lourdes Ibáñez
Scientific

Hospital Sant Joan de Déu, University of Barcelona
Esplugues, Barcelona
08950
Spain

Study information

Study designRandomised 2 arm open-labeled active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet.
Scientific titleEthynil-estradiol cyproterone acetate versus low-dose metformin-flutamide-pioglitazone in girls with hyperinsulinemic androgen excess: effects on parameters of chronic inflammation, and on risk factors for type 2 diabetes and cardiovascular disease
Study acronymDIO
Study hypothesisLow-dose metformin-flutamide-pioglitazone will prove to be superior to ethynil-estradiol-cyproterone acetate in improving chronic inflammation and risk factors for type 2 diabetes and cardiovascular disease

Please note that as of 08/02/2011 the study has been updated. The study design of this trial has changed from a "Randomised 2 arm double blind active controlled parallel group trial" to a "Randomised 2 arm open-labeled active controlled parallel group trial".
Ethics approval(s)CEIC Fundacio Sant Joan de Déu approved on the 7th of October 2009
ConditionHyperinsulinemic ovarian androgen excess
InterventionCurrent interventions as of 08/02/2011:
Adolescents with androgen excess will be allocated to treatment with metformin-flutamide-pioglitazone or ethynil-estradiol-cyproterone acetate over 18 months.

Auxology, blood counts, liver and renal functions, endocrine-metabolic parameters (fasting blood) and body composition will be measured at 0 and 18 mo and at 6 mo after treatment stop

Previous interventions:
Adolescents with androgen excess will be allocated to treatment with metformin-flutamide-pioglitazone or ethynil-estradiol-cyproterone acetate over 12 months.

Auxology, blood counts, liver and renal functions, endocrine-metabolic parameters (fasting blood) and body composition will be measured at 0 and 12 mo and at 6 mo after treatment stop.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Ethynil-estradiol cyproterone acetate, metformin-flutamide-pioglitazone
Primary outcome measure1. Insulin sensitivity measured by Homeostasis Model Assessment (HOMA)
2. Insulin
3. Abdominal fat measured by Dual Energy X-Ray Absorptiometry (DXA)
4. Abdominal visceral fat and intrahepatic lipid content
5. Intermuscular Adipose Tissue (IMAT) measured by Magnetic Resonance (MR)
6. Carotid intima media thickness (IMT) measured by Doppler sonography
Secondary outcome measures1. Hirsutism measured by Ferriman & Gallwey score
2. Androgens
3. Triglycerides
4. Ultrasensitive C-reactive protein
5. Neutrophile/lymphocyte ratio
6. High molecular weight adiponectin
7. Changes in the size, number, and distribution of adipocytes determined by subcutaneous adipose tissue biopsy
Overall study start date01/02/2010
Overall study end date05/11/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit14 Years
Upper age limit17 Years
SexFemale
Target number of participants46
Participant inclusion criteria1. Adolescent girls (14-17 yr)
2. Two or more yr beyond menarche
3. BMI less than the 97th centile for age
4. Clinical and biochemical signs of androgen excess (hirsutism [Ferriman & Gallwey score >8] and/or acne and/or menstrual irregularities)
5. Total testosterone >60 ng/dL and/or free androgen index >5
6. Hyperinsulinism: fasting insulin >15 uU/mL; glucose/insulin ratio <7, or peak insulin after an OGTT >100 uU/mL
Participant exclusion criteria1. Pregnancy or pregnancy risk
2. Late-onset congenital adrenal hyperplasia due to 21-OH deficiency
3. Hyperprolactinemia
4. Cushing's syndrome
5. Hypothyroidism
6. Abnormal liver or kidney function, Creatine Phosphokinase (CPK) or Lactate Dehydrogenase (LDH)
6. Diabetes or impaired glucose tolerance
7. Cutaneous allergies
8. Treatment with anti-androgens, estroprogestagens, or medications interfering with lipid and carbohydrate metabolism during the previous 6 mo
9. Bacterial infections
10. Inflammatory intestinal conditions
Recruitment start date01/02/2010
Recruitment end date05/11/2011

Locations

Countries of recruitment

  • Spain

Study participating centre

Hospital Sant Joan de Déu, University of Barcelona
Esplugues, Barcelona
08950
Spain

Sponsor information

Hospital Sant Joan de Déu (Spain)
Hospital/treatment centre

University of Barcelona.
Passeig de Sant Joan de Déu, 2
Esplugues
Barcelona
08950
Spain

ROR logo https://ror.org/001jx2139

Funders

Funder type

Hospital/treatment centre

Instituto de Salud Carlos III (Spain) (ref: PI09/90444)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2011 Yes No
Results article results 01/10/2012 Yes No
Results article results 01/05/2013 Yes No
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