Metformin Suspension and Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00437333
First received: February 20, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the long-term metformin administration are know but no data are available on the effects after its suspension.

The purpose of this study is to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients.


Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin cloridrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Insulin Sensitivity After Metformin Suspension in Normal-Weight Women With Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Insulin sensitivity by euglycemic hyperinsulinemic clamp

Secondary Outcome Measures:
  • Clinical, hormonal, and metabolic assessments

Estimated Enrollment: 30
Study Start Date: December 2003
Estimated Study Completion Date: April 2006
Detailed Description:

Thirty young normal-weight anovulatory PCOS women will be enrolled. The diagnosis of PCOS will be based on the presence of clinical [Ferriman-Gallwey score ≥ 8] or biochemical hyperandrogenism (serum testosterone levels (>2 SD above our reference mean values) and chronic anovulation [serum luteal progesterone (P) below 2 ng/mL)].

Patients will be randomly allocated into two groups (metformin and placebo group) using a computer-software. Fifteen PCOS patients will be treated with metformin at a dosage of 1700 mg daily (one tablet of 850 mg twice daily; metformin group), whereas other 15 PCOS will be treated with placebo tables (one tablet twice daily; placebo group). The duration of the treatment will be 12 months. Patients will be instructed to follow their usual diet and physical activity, and to use barrier contraception throughout the study. The length and the frequency of the menstrual cycles, and the adverse experiences (AEs) will be reported on a daily diary.

Each subject will undergo follow-up visits under (at six and 12 months from treatment starting) and after treatment (at six and 12 months from treatment withdrawal). At each follow-up visit, in all subjects the same operator will perform clinical, hormonal, metabolic, and insulin sensitivity assessments by euglycemic hyperinsulinemic clamp.

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Polycystic ovary syndrome (using NIH criteria).

Exclusion Criteria:

  • Age <20 or >30 years;
  • BMI higher than 25 and lower than 18;
  • Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses;
  • Hypothyroidism, hyperprolactinemia, Cushing’s syndrome, and non-classical congenital adrenal hyperplasia;
  • Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs;
  • Intention to start a diet or a specific program of physical activity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437333

Locations
Italy
"Pugliese" Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Stefano Palomba, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00437333     History of Changes
Other Study ID Numbers: MM-187-2004, Prot. 2004063411_003
Study First Received: February 20, 2007
Last Updated: February 20, 2007
Health Authority: Italy: Italian Institute of Health

Keywords provided by University Magna Graecia:
Insulin sensitivity
Insulin-sensitizing drug
Metformin
PCOS
Treatment

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
Insulin
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014