Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS - Full Text View

Sponsor:	Hippocration General Hospital
Information provided by:	Hippocration General Hospital
ClinicalTrials.gov Identifier:	NCT00463112

Purpose

Studies on the effect of sibutramine, an anti-obesity drug, on hormonal and metabolic features of women with polycystic ovary syndrome (PCOS) are lacking.

The objective of this study is to examine the effect of sibutramine plus hypocaloric diet on body composition, hormonal and metabolic parameters and insulin resistance in obese patients with PCOS.

Overweight and obese women with PCOS were placed in a hypocaloric diet plus sibutramine (10 mg/day) for the first month and then on a hypocaloric diet plus sibutramine (10 mg/day) or hypocaloric diet only for the subsequent 6 months.

The main outcome measures are: Body composition, hormonal and metabolic features and insulin sensitivity (OGTT) at baseline, at 3 and 6 months of treatment.

Condition	Intervention	Phase
Obesity Polycystic Ovary Syndrome	Drug: Sibutramine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS: a Randomized, 24-Week Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity Polycystic Ovary Syndrome Weight Control

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

Further study details as provided by Hippocration General Hospital:

Primary Outcome Measures:

weight loss

Secondary Outcome Measures:

FAI, insulin resistance and other metabolic parameters

Estimated Enrollment:	80
Study Start Date:	March 2004
Study Completion Date:	September 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

overweight and obese women with PCOS

Exclusion Criteria:

Nonclassical 21-hydroxylase deficiency, hyperprolactinemia, adrenal or ovarian tumor and Cushing’s disease, hypertension, thyroid dysfunction, overt diabetes mellitus and concomitant treatment such as antihypertensive drugs, SSRI or other SNRI drug, oral contraceptive pills or any other antiandrogen treatment (cyproterone acetate, spirolactone, LHRH agonist) and insulin sensitizing agents (metformin, pioglitazone, roziglitazone) that may interact with insulin sensitivity and lipid profile.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463112

Locations

Greece
Hippocratio General Hospital
Thessaloniki, Greece, 54642

Sponsors and Collaborators

Hippocration General Hospital

Investigators

Principal Investigator:

Dimos Florakis, MD

Divison of Endocrinology and Human Reproduction, Second Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Greece

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00463112 History of Changes
Other Study ID Numbers:	511/8-1-04
Study First Received:	April 19, 2007
Last Updated:	April 19, 2007
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hippocration General Hospital:

Obesity
Polycystic Ovary Syndrome
weight loss
Hyperadrogonemia
Sibutramine

Additional relevant MeSH terms:

Obesity
Polycystic Ovary Syndrome
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Sibutramine
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 13, 2012