NCT00231608

Brief Summary

The purposes of this study are to compare the effects of Topiramate and placebo on abdominal visceral fat accumulation at 6 months and to evaluate the safety of Topiramate for up to 12 months of continued treatment in male patients with abdominal obesity.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Dec 1998

Typical duration for phase_2 obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1998

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

June 8, 2011

Status Verified

April 1, 2010

First QC Date

September 30, 2005

Last Update Submit

June 6, 2011

Conditions

Obesity

Keywords

ObesityAbdominal ObesityVisceral FatSubcutaneous FatDislipidemiaHypertensionType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • The mean change from baseline to Month 6 in abdominal visceral fat as assessed by computed tomography; the safety of Topiramate for up to 12 months of continued treatment in male subjects with abdominal obesity.

Secondary Outcomes (1)

  • Mean change and percent change in body weight, and mean change in total abdominal fat, subcutaneous abdominal fat, body composition, and body mass index from baseline to Month 6.

Interventions

topiramateDRUG

Eligibility Criteria

Age25 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>= 27 and =\< 40
  • a waist circumference \>= 100 cm (39.4 inches)
  • Baseline weight must be stable (varying no more than 4 kg (8.8 lbs)) for at least two months prior to enrollment
  • Must be sedentary (less than one session of continuous moderate physical activity of 30 min/week)
  • Must have blood lipid disorder
  • Must be non-smokers

You may not qualify if:

  • Patients with endocrine disease or other physical causes of obesity
  • Patients with significantly abnormal hepatic liver function tests or renal disease
  • History of schizophrenia, psychotic, or major affective disorder
  • History of epilepsy
  • History of eating disorders
  • History of any other significant medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

ObesityObesity, AbdominalHypertensionDiabetes Mellitus, Type 2

Interventions

Topiramate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

December 1, 1998

Study Completion

January 1, 2002

Last Updated

June 8, 2011

Record last verified: 2010-04