PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives
Effects of Metformin Versus Oral Contraceptives on PED/PEA-15 Protein Expression in Obese Women With Polycystic Ovary Syndrome
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Insulin-resistance plays an important role in polycystic ovary syndrome (PCOS) physiopathology. The phosphoprotein enriched in the diabetes (PED/PEA-15), a 15 kDa protein related to insulin sensitivity, is over-expressed in type 2 diabetic patients and in PCOS women, independently of obesity. The effectiveness of oral contraceptives pills (OCP) or metformin (MET) in PCOS management is still uncertain. Aim of this pilot clinical study was to compare the effects of OCPs or MET on the expression of PED/PEA-15 in association with insulin sensitivity in obese PCOS women. Outcome measures: PED/PEA-15, BMI, plasma glucose and insulin, 1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI: whole-body insulin sensitivity index. Study design: twenty obese PCOS women (age: 24.7±18 yr; BMI: 30±2.4 kg/m2) were randomized according to insulin sensitivity to receive 30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month or MET 1250 mg three times daily for 6 months. Results: At baseline, age and BMI were not different in the two groups; PED/PEA-15 protein expression was higher in MET than in OCP group (p=0.011), along with higher 1/HOMA-IR (p=0.004), and lower QUICKI and ISI (p=0.003 and p\<0.001, respectively). After treatment, independently of body weight, only in MET group PED/PEA-15 decreased (p=0.004), along with insulin and 1/HOMA-IR (p\<0.001), and QUICKI and ISI increased (p\<0.001). Insulin sensitivity indexes improvement correlated significantly with PED/PEA-15 protein expression, but not with BMI. Conclusions: PED/PEA-15 protein over-expression in obese PCOS women with IR reduced after a six month treatment with MET, while remained unchanged in the OCP group. The reduction was independent of body weight, and correlated with insulin sensitivity indexes. This effect further supported MET as a more effective therapy than OCPs for obese PCOS women with IR, also when fertility is not required.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
July 29, 2009
CompletedOctober 14, 2009
October 1, 2009
Same day
July 24, 2009
October 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PED/PEA-15 protein expression
6 months
Secondary Outcomes (1)
BMI, plasma glucose, plasma insulin, insulin sensitivity indexes (1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI, whole-body insulin sensitivity index).
6 months
Study Arms (2)
metformin
EXPERIMENTALoral contraceptive
ACTIVE COMPARATORInterventions
30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month.
Eligibility Criteria
You may qualify if:
- female
- premenopausal
- obesity
- PCOS.
You may not qualify if:
- pregnancy
- type 2 diabetes or impaired glucose tolerance
- hypothyroidism
- hyperprolactinaemia
- Cushing's syndrome
- nonclassical congenital adrenal hyperplasia
- previous (within the last 6 months) use of oral contraceptives
- glucocorticoids
- antiandrogens
- ovulation induction agents
- antidiabetic and antiobesity drugs, or other hormonal drugs.
- None of the subjects was affected by any neoplastic, metabolic, hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, and malabsorptive disorders),acute and chronic inflammations based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Savastano S, Di Somma C, Pizza G, De Rosa A, Nedi V, Rossi A, Orio F, Lombardi G, Colao A, Tarantino G. Liver-spleen axis, insulin-like growth factor-(IGF)-I axis and fat mass in overweight/obese females. J Transl Med. 2011 Aug 16;9:136. doi: 10.1186/1479-5876-9-136.
PMID: 21846339DERIVEDSavastano S, Valentino R, Pizza G, De Rosa A, Orio F, Passaretti F, Formisano P, Lombardi G, Beguinot F, Colao A. Preliminary data on effects of metformin on PED/PEA-15 cellular levels in obese women with polycystic ovary syndrome. J Endocrinol Invest. 2010 Jul-Aug;33(7):446-50. doi: 10.1007/BF03346622.
PMID: 20671408DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annamaria Colao, MD PhD
Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 24, 2009
First Posted
July 29, 2009
Study Start
December 1, 2006
Primary Completion
December 1, 2006
Study Completion
January 1, 2009
Last Updated
October 14, 2009
Record last verified: 2009-10