Evidence map›Paper›PMID 21325466›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2011

Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors.

Hala Tfayli, Julia Warren Ulnach, SoJung Lee, Kim Sutton-Tyrrell, Silva Arslanian

Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00640224 (Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
3.3field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00640224 phase4completednot on this map

Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives

TypeinterventionalSponsorSilva ArslanianRan2005 to 2015Enrolled65ConditionsPolycystic Ovary SyndromeArmsrosiglitazone, drospirenone/ethinyl estradiol
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 44 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. Polycystic Ovary Syndrome in Adolescents: Challenges in Diagnosis and Treatment.International journal of endocrinology and metabolism · 2019
    Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Anti-Müllerian Hormone in Obese Adolescent Girls With Polycystic Ovary Syndrome.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2017
    Article
  13. Article
  14. Article
  15. Article
  16. Cardiovascular risk factors and events in women with androgen excess.Journal of endocrinological investigation · 2015
    Review
  17. PCOS in adolescence and type 2 diabetes.Current diabetes reports · 2015
    Review
  18. Hyperinsulinaemic androgen excess in adolescent girls.Nature reviews. Endocrinology · 2014
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Hala TfayliDivision of Weight Management and Wellness, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15224, USA.
Julia Warren Ulnach
SoJung Lee
Kim Sutton-Tyrrell
Silva Arslanian
University of Pittsburgh Medical Center · USChildren's Hospital of Pittsburgh · USUniversity of Pittsburgh · US

Funding

UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
WATER PRECAUTIONS AND TYMPANOSTOMY TUBESM01RR000084 · NCRR · CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS · PI PERLMUTTER, DAVID H · 1985 to 2006
$5.6M
INSULIN RESISTANCE IN CHILDHOODK24HD001357 · NICHD · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ARSLANIAN, SILVA A · 2000 to 2011
$1.0M
Research and Academic Training in Pediatric DiabetesT32DK063686 · NIDDK · CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS · PI ARSLANIAN, SILVA A · 2003 to 2007
$791k
Physical Activity in Overweight Girls: Implications for Reversing Risk Factors foR21DK083654 · NIDDK · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI LEE, SOJUNG · 2010 to 2011
$401k
NCRR NIH HHS M01 RR000084NCRR NIH HHS M01-RR00084NCRR NIH HHS UL1 RR024153NICHD NIH HHS K24 HD001357NICHD NIH HHS K24-HD01357NIDDK NIH HHS R21 DK083654NIDDK NIH HHS T32 DK063686
6 · The paper itself

Abstract

contextAdolescents with polycystic ovary syndrome (PCOS) have insulin resistance and higher rates of the metabolic syndrome.

objectiveOur objective was to compare the effects of 6 months treatment with drospirenone/ethinyl estradiol (EE) (3 mg/30 μg) vs. rosiglitazone (4 mg) daily on the hormonal and cardiometabolic profiles of overweight/obese adolescents with PCOS.

designWe conducted a randomized, double-blinded, parallel clinical trial in an academic hospital, with n = 46 patients. OUTCOME MEASURES: The primary outcome measure was insulin sensitivity, hepatic with [6,6-(2)H(2)]glucose and peripheral with a 3-h hyperinsulinemic-euglycemic clamp. Other outcome measures included plasma androgen profile and response to ACTH stimulation, glucose and insulin response to oral glucose tolerance test, insulin secretion with a 2-h hyperglycemic clamp, fasting lipid profile, inflammatory markers, intima media thickness, aortic pulse wave velocity, body composition by dual-energy x-ray absorptiometry, and abdominal adiposity by computed tomography scan.

resultsDrospirenone/EE resulted in greater reductions in androgenemia. Neither treatment led to change in weight or body mass index, but rosiglitazone led to a significant decrease in visceral adiposity. Compared with drospirenone/EE, treatment with rosiglitazone improved hepatic and peripheral insulin sensitivity and lowered fasting and stimulated insulin levels during the oral glucose tolerance test. Treatment with drospirenone/EE was associated with elevations in total cholesterol, high-sensitivity C-reactive protein and leptin concentrations, whereas treatment with rosiglitazone led to lower triglycerides and higher adiponectin concentrations. Neither treatment affected intima media thickness or pulse wave velocity.

conclusionsIn overweight/obese adolescents with PCOS, 6 months treatment with rosiglitazone was superior to drospirenone/EE in improving the cardiometabolic risk profile, and effective but inferior in attenuating hyperandrogenemia. Additional studies are needed to test insulin sensitizers in the treatment of the reproductive and cardiometabolic aspects of PCOS.

Indexed as

AdolescentAdrenocorticotropic HormoneAndrostenesBody CompositionCardiovascular DiseasesDouble-Blind MethodEthinyl EstradiolFemaleGlucose Clamp TechniqueGlucose Tolerance TestHemodynamicsHormonesHumansHyperandrogenismHypoglycemic AgentsInsulin ResistanceAdrenocorticotropic HormoneAndrostenesdrospirenoneEthinyl EstradiolHormonesHypoglycemic AgentsMineralocorticoid Receptor AntagonistsRosiglitazoneThiazolidinediones

Identifiers

PMID21325466
PMCPMC3203622
OpenAlexW2081498288

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.