NCT00948402

Effects of Metformin Versus Oral Contraceptives on PED/PEA-15 Protein Expression in Obese Women With Polycystic Ovary Syndrome

Completed Phase 3 Last updated 13 October 2009

What this trial tests

Phase 3 trial testing Metformin in Polycystic Ovarian Syndrome in 20 participants. Completed in 1 January 2009.

Timeline

1 December 2006

Primary endpoint
1 December 2006

1 January 2009

Quick facts

Lead sponsor	Federico II University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 December 2006
Primary completion	1 December 2006
Estimated completion	1 January 2009

Drugs / interventions tested

• Metformin (metformin) — full drug profile →
• oral contraceptive — full drug profile →

Conditions studied

• Polycystic Ovarian Syndrome — all drugs for Polycystic Ovarian Syndrome →
• Insulin Sensitivity — all drugs for Insulin Sensitivity →

Sponsor

Federico II University

Who can join

Adults 21 to 28, female only, with Polycystic Ovarian Syndrome or Insulin Sensitivity. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• PED/PEA-15 protein expression
  Time frame: 6 months

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Liver-spleen axis, insulin-like growth factor-(IGF)-I axis and fat mass in overweight/obese females.
   Savastano S, Di Somma C, Pizza G, De Rosa A, et al · · 2011 · cited 43× · PMID 21846339 · DOI 10.1186/1479-5876-9-136