PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00948402
First received: July 24, 2009
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Polycystic Ovarian Syndrome
Insulin Sensitivity
Drug: Metformin
Drug: oral contraceptive
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Metformin Versus Oral Contraceptives on PED/PEA-15 Protein Expression in Obese Women With Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • PED/PEA-15 protein expression [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2006
Study Completion Date: January 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: metformin Drug: Metformin
metformin 1250 mg three times daily
Other Name: Biguanides
Active Comparator: oral contraceptive Drug: oral contraceptive
30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month.
Other Name: estroprogestins

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 28 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female
  • premenopausal
  • obesity
  • PCOS.

Exclusion Criteria:

  • 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.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00948402

Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Annamaria Colao, MD PhD Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples
  More Information

No publications provided by Federico II University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Annamaria Colao, Dept of Moll Clin Endocrinol Oncol, University Federico II of Naples
ClinicalTrials.gov Identifier: NCT00948402     History of Changes
Other Study ID Numbers: NeuroendoUnit-11
Study First Received: July 24, 2009
Last Updated: October 13, 2009
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Institute of Health

Keywords provided by Federico II University:
PED/PEA-15 protein
PCOS
IR
metformin
OCP
Oral Contraceptive

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Glucose Metabolism Disorders
Gonadal Disorders
Hyperinsulinism
Metabolic Diseases
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Contraceptive Agents
Contraceptives, Oral
Metformin
Contraceptive Agents, Female
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014