Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

NCT00243984 | Suspended Phase 3

• 1 other identifier: 05005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the efficacy of topiramate compared to placebo in the treatment of obesity in metabolic syndrome. Secondary objectives include topiramate and weight loss effects on lipid levels, HbA1C, insulin resistance, and blood pressure.

Conditions

Metabolic Syndrome X; Diabetes Mellitus, Type 2

Keywords

metabolic syndrome; type 2 diabetes; topiramate; weight loss

Outcome Measures

Primary Outcomes (3)

• Change in weight on days 28, 56, 84, 112, 140, 168, and 175.

• Waist circumference on days 1, 84 and 168.

• BMI on days 1, 84, 168, and 175.

Secondary Outcomes (5)

• Blood pressure on days 1, 28, 56, 84, 112, 140, 168, and 175.

• Complete metabolic profile on days 84 and 168.

• HbA1C on days 1, 84, and 168.

• Lipid profile on days 84 and 168.

• C reactive protein on days 1, 84, and 168.

Interventions

topiramate DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Metabolic Syndrome
• BMI \>/=30kg/m2
• and 3 of the 5 following criteria:
• Triglycerides \>/=150mg/dl
• HDL cholesterol \</=40mg/dl (men) or \</=50mg/dl (women)
• Blood pressure \> 130/85
• Waist circumference \>/=40inches (men) or \>/=35inches (women)
• Fasting blood glucose \>/=110mg/dl or diagnosis of type 2 diabetes mellitus
• Able to give informed consent
• Diabetes Mellitus must be well controlled for the past 3 months and HbA1c \</=9.0
• Hypertension must be well controlled for the past 3 months and BP \<140/90
• Willing and able to take oral medication
• Female subjects must be post menopausal for 1 year, surgically sterile, or practicing an effective method of birth control; and have a negative monthly pregnancy test at screening and throughout the study.

You may not qualify if:

• Any person unable to take topiramate
• Renal insufficiency
• Taking medication with known serious interactions with topiramate
• History of psychosis, epilepsy or any other disease in which taking topiramate may interfere with treatment of that disease
• Positive urine drug screen
• Previous treatment with topiramate and subsequent adverse event; or concurrent treatment with topiramate
• History of nephrolithiasis
• Pregnancy or lactating
• Subjects who are members of the same household
• Currently on an exercise or diet plan
• Bariatric surgery within the past 5 years
• Clinically significant medical conditions including (but not limited to) symptomatic coronary artery disease or peripheral vascular disease, or taking nitrates; malignancy or history of malignancy within the past 5 years (except basal cell carcinoma); Impaired renal function as defined by an estimated creatinine clearance \</=60ml/min; Gastrointestinal system diseases including active liver disease; ALT or AST\>2 times the upper limit of normal; Pulmonary disorders; Endocrine disorders except for well controlled diabetes mellitus and hypothyroidism; Any disease or condition that compromises the function of those body systems that could result in altered absorption, excess accumulation, or impaired metabolism or excretion of topiramate.
• Subjects who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings, or contraindications sections of the topiramate package insert
• Family members of employees or investigators and employees of the investigator or study center may participate but may not serve any staff role for themselves.

Sponsors & Collaborators

• Northeastern Ohio Universities College of Medicine: lead
• Cleveland Clinic Akron General: collaborator
• Forum Health: collaborator
• Aultman Health Foundation: collaborator
• St. Elizabeth Health Center: collaborator
• Mercy Medical Center: collaborator

Study Sites (5)

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Mercy Medical Center

Canton, Ohio, 44708, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Forum Health/Northside Medical Center

Youngstown, Ohio, 44501, United States

Location

St. Elizabeth Health Center

Youngstown, Ohio, 44501, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus, Type 2; Weight Loss

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Frederick Whittier, MD

  Northeastern Ohio Universities College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 21, 2005
• First Posted: October 25, 2005
• Study Start: March 1, 2005
• Study Completion: November 1, 2007
• Last Updated: December 10, 2007

Record last verified: 2007-12

Locations

US (5)