Metabolic Syndrome XPhase 3NCT00243984
Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome
A Phase 3 study testing topiramate in people with Metabolic Syndrome X and Diabetes Mellitus, Type 2, run by Northeastern Ohio Universities College of Medicine at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome X, Diabetes Mellitus, Type 2
- What is being tested?
- topiramate
- How many people
- 90 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2005to Nov 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Akron General Medical Center
Akron, Ohio, 44307
Mercy Medical Center
Canton, Ohio, 44708
Aultman Hospital
Canton, Ohio, 44710
Forum Health/Northside Medical Center
Youngstown, Ohio, 44501
St. Elizabeth Health Center
Youngstown, Ohio, 44501
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome
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.
Read the detailed description
Topiramate is an anti-convulsant which has been approved for use as adjunctive treatment for partial-onset seizures, Lennox-Gastaut syndrome, or primary generalized tonic-clonic seizures. Topiramate is currently under investigation for other disorders including binge-eating disorder.
Metabolic syndrome is a constellation of findings which includes dyslipidemia, abdominal obesity, hyperglycemia, and hypertension. Insulin resistance is believed to be the cause whereby obesity increases resistance to insulin. Weight loss in type 2 diabetics is known to reduce insulin resistance and allow for greater glycemic control. Weight loss in pre-diabetics can often forstall the development of diabetes. Additionally, aggressive blood pressure control in diabetics reduces the risk of coronary artery disease. Weight loss reduces blood pressure and is used as first line treatment for hypertension.
Comparison: Patients who meet the criteria for metabolic syndrome and prescribed topiramate will be compared with those patients who meet the same criteria and are prescribed placebo.
- Conditions
- Metabolic Syndrome X, Diabetes Mellitus, Type 2
- Being tested
- topiramate
- Keywords
- metabolic syndrome, type 2 diabetes, topiramate, weight loss
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startMar 2005
- Study completionNov 2007 (estimated)
Why it stopped: Study was discontinued because of high drop out rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern Ohio Universities College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Cleveland Clinic Akron General, Forum Health, Aultman Health Foundation, St. Elizabeth Health Center, Mercy Medical Center
- Investigators
- Frederick Whittier, MD, Principal investigator, Northeastern Ohio Universities College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243984
- Sponsor's protocol ID
- 05005
- Status last verified
- Dec 2007
- First submitted
- 21 Oct 2005
- Last updated
- 10 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00243984
- Acronym / sponsor ID
- 05005
- Conditions
- Metabolic Syndrome X, Diabetes Mellitus, Type 2
- Keywords
- metabolic syndrome, type 2 diabetes, topiramate, weight loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study was discontinued because of high drop out rate.
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Northeastern Ohio Universities College of MedicineUniversity, hospital or other
- Collaborators
- Cleveland Clinic Akron General, Forum Health, Aultman Health Foundation, St. Elizabeth Health Center, Mercy Medical Center
- Study start
- Mar 2005
- Study completion
- Nov 2007 (estimated)
- First posted
- 25 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Topiramate is an anti-convulsant which has been approved for use as adjunctive treatment for partial-onset seizures, Lennox-Gastaut syndrome, or primary generalized tonic-clonic seizures. Topiramate is currently under investigation for other disorders including binge-eating disorder.
Metabolic syndrome is a constellation of findings which includes dyslipidemia, abdominal obesity, hyperglycemia, and hypertension. Insulin resistance is believed to be the cause whereby obesity increases resistance to insulin. Weight loss in type 2 diabetics is known to reduce insulin resistance and allow for greater glycemic control. Weight loss in pre-diabetics can often forstall the development of diabetes. Additionally, aggressive blood pressure control in diabetics reduces the risk of coronary artery disease. Weight loss reduces blood pressure and is used as first line treatment for hypertension.
Comparison: Patients who meet the criteria for metabolic syndrome and prescribed topiramate will be compared with those patients who meet the same criteria and are prescribed placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of Metabolic Syndrome
- BMI >/=30kg/m2
- and 3 of the 5 following criteria:
- Able to give informed consent
- Diabetes Mellitus must be well controlled for the past 3 months and HbA1c </=9.0
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topiramate | Drug | – |
Primary outcome
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.
5 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Whittier, MD principal investigator
Northeastern Ohio Universities College of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topiramate in people with Metabolic Syndrome X and Diabetes Mellitus, Type 2, run by Northeastern Ohio Universities College of Medicine at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight on days 28, 56, 84, 112, 140, 168, and 175.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2007.