Trial record 6 of 649 for:
"Abdominal obesity metabolic syndrome"
Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity (REVIVE)
This study is currently recruiting participants.
Verified April 2012 by University of Iowa
Sponsor:
University of Iowa
Information provided by (Responsible Party):
William G. Haynes, University of Iowa
ClinicalTrials.gov Identifier:
NCT01351753
First received: May 4, 2011
Last updated: April 16, 2012
Last verified: April 2012
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Purpose
Obesity is common (>30% of US adults), contributes to substantial morbidity and mortality, but is difficult to treat. Partly this is due to the transient, arduous and modest nature of lifestyle interventions. Partly it is due to the limited efficacy and safety problems of existing pharmacotherapy. Only one drug, orlistat, is approved for long-term use in obesity; but its effects on weight are relatively small. There are drugs that have been approved for other diseases but which also reduce weight. One promising approach to treating obesity is combination therapy with orlistat and one or more of these other agents. The investigators propose an innovative approach to developing new therapies for obesity coupling the use of combination therapy with rigorous assessment of cardiovascular safety. Vascular function is a quantitative surrogate clinical endpoint that has been strongly and independently linked to future cardiovascular events.
Our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular function in obese human subjects. The co-primary endpoints will be weight and vascular function.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Metabolic Syndrome X |
Drug: Metformin Drug: Orlistat Drug: Topiramate Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Does Reversal of Visceral Obesity by Drug Therapy Improve Vascular Function? |
Resource links provided by NLM:
Further study details as provided by University of Iowa:
Primary Outcome Measures:
- Weight (change from baseline) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Weight obtained in the fasting state on a gowned subject.
- Brachial artery flow mediated dilatation (change from baseline) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Conduit artery flow mediated dilatation (FMD) assessed using ultrasound-Doppler.
Secondary Outcome Measures:
- Number of subjects with mild, moderate and serious adverse events. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Gastrointestinal, central nervous system, psychiatric, hepatic, renal, musculoskeletal and other adverse effects will be regularly assessed
- Systolic and diastolic systemic arterial pressure (change from baseline) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Automated sphygmomanometry while sitting and 24-hour ambulatory BP monitoring.
- Fasting lipids, glucose and other biomarkers of obesity risk (change from baseline) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Fasting total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, hsCRP, glucose, HBA1c, ALT, creatinine, eGFR, microalbuminuria, EKG voltage
- Mood, anxiety, quality of life and cognitive function (change from baseline) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Mood assessed using Beck Depression Inventory. Anxiety assessed using Beck Anxiety Inventory. Quality of life assessed using SF-36 and IWQOL surveys. Cognition assessed using Trail Making A & B, Controlled Oral Word Association, and Letter-Number Sequencing Tests.
- Body fat distribution (change from baseline) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Body fat distribution measured using anthropometry (waist, neck and hip circumferences), as well as air displacement plethysmography, electrical bioimpedance, and DEXA in subsets of subjects.
- Pulse wave velocity (PWV) and aortic augmentation pressure (change from baseline) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Carotid-femoral pulse wave velocity and estimated aortic augmentation pressure measured using pulse tonometry (Sphygmocor).
- Peripheral arteriolar tonometry [ Time Frame: 12 months ] [ Designated as safety issue: No ]Reactive hyperemia in finger tip measured using EndoPAT.
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Metformin | Drug: Metformin |
| Experimental: Metformin + Orlistat | Drug: Metformin Drug: Orlistat |
| Experimental: Metformin + Topiramate | Drug: Metformin Drug: Topiramate |
| Experimental: Topiramate | Drug: Topiramate |
| Experimental: Metformin + Topiramate + Orlistat | Drug: Metformin Drug: Orlistat Drug: Topiramate |
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo pills and capsules for metformin, orlistat and topiramate
|
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 40 to 75 years
- Male or postmenopausal female
- BMI ≥ 30 kg/m2
- One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome)
Exclusion Criteria:
- Congestive heart failure
- Renal impairment
- History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion)
- Type I diabetes mellitus
- Weight loss > 10% in the past 6 months
- Recurrent nephrolithiasis
- Current treatment for seizure disorder
- Hepatic cirrhosis
- Current use of study medications
- Current use of oral estrogen
- History of smoking cessation in the past three months
- Current cholestasis or malabsorption syndrome
- Planned use of any herbal or over-the-counter supplements for weight loss
- History of allergic reactions to metformin, topiramate, orlistat or any of ingredients
- Medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours
- Participation in another clinical drug study within four weeks prior to this investigation.
- Participation in any other weight loss or rigorous exercise program.
- Any disease or condition that in the opinion of the investigator may interfere with completion of the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351753
Contacts
| Contact: William G Haynes, MD | revive@uiowa.edu |
Locations
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52241 | |
| Contact: Graziela Kalil, Pharm.D. 319-356-2710 graziela-kalil@uiowa.edu | |
| Principal Investigator: William G Haynes, MD | |
| Principal Investigator: Graziela Z Kalil, PharmD | |
Sponsors and Collaborators
University of Iowa
Investigators
| Principal Investigator: | William G Haynes, MD | University of Iowa |
More Information
Additional Information:
No publications provided
| Responsible Party: | William G. Haynes, Professor, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT01351753 History of Changes |
| Other Study ID Numbers: | UI 201012738 |
| Study First Received: | May 4, 2011 |
| Last Updated: | April 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Iowa:
|
Obesity Metabolic Syndrome X Hypertension Dyslipidemia Impaired glucose tolerance |
Additional relevant MeSH terms:
|
Metabolic Syndrome X Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Metformin Orlistat |
Topiramate Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses Anticonvulsants Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013