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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Collaborator: |
Washington University School of Medicine |
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00455325 |
Purpose
Metabolic syndrome consists of a group of co-occuring conditions that increase an individual's risk of developing heart disease, stroke, and diabetes. The purpose of this study is to evaluate the short-term effectiveness of chloroquine, a protein-activation medication, at improving metabolic syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome X Overweight Hypertension Dyslipidemias Prediabetic State |
Drug: Chloroquine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Efficacy Study |
| Official Title: | Genotoxic Stress, Atherosclerosis, and Metabolic Syndrome-AIM 2 |
| Estimated Enrollment: | 25 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Limb 1: Placebo Comparator |
Drug: Chloroquine
1 chloroquine placebo tablet for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
|
| Limb 2: Active Comparator |
Drug: Chloroquine
Weeks 1-3 daily tablet of either 80mg chloroquine or placebo;euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
|
| Limb 3: Active Comparator |
Drug: Chloroquine
80mg tablet daily for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
|
| Limb 4: Active Comparator |
Drug: Chloroquine
250mg tablet daily for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
|
Metabolic syndrome is one of the most common disorders in industrialized countries. It consists of abnormal serum lipids, glucose intolerance, elevated blood pressure, and central obesity in the setting of insulin resistance. The syndrome substantially increases the risk of developing diabetes and vascular disease, but there is no clear unifying approach to treat this disorder. In animals, activation of the protein ataxia telangiectasia mutated (ATM) using the antimalarial drug chloroquine improves features of metabolic syndrome and decreases atherosclerosis, a build-up of fatty plaque within arteries. The purpose of this study is to evaluate the effectiveness of short-term treatment with low doses of chloroquine as a way of managing metabolic syndrome.
Participants in this study will initially receive placebo for 3 weeks, followed by increasing doses of chloroquine in 3-week intervals. There will be a period of no active treatment for 5 to 7 weeks between each arm. At the end of each 3-week period, participants will be admitted to the research center and will undergo insulin sensitivity testing with the hyperinsulinemic euglycemic clamp procedure. In addition, blood will be collected and blood pressure will be measured.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of metabolic syndrome, as determined by at least three of the following five criteria:
Exclusion Criteria:
Prior travel treatment with chloroquine or hydroxychloroquine as follows:
Contacts and Locations| Contact: Mariko Johnson, MD | 314-294-4453 | mkjohnson@dom.wustl.edu |
| Contact: Janet B. McGill, MD | 314-362-8681 | jmcgill@dom.wustl.edu |
| United States, Missouri | |
| Washington University in St. Louis | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Clay F. Semenkovich, MD | Washington University in St. Louis |
More Information
| Responsible Party: | Washington University ( Clay Semenkovich, MD/ Professor, Medicine; Director: Division of Endocrinology, Metabolism and Lipid Research ) |
| Study ID Numbers: | 395, P50 HL083762 |
| Study First Received: | March 30, 2007 |
| Last Updated: | July 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00455325 History of Changes |
| Health Authority: | United States: Federal Government |
|
Insulin Resistance Atherosclerosis Metabolic Syndrome |
|
Anti-Inflammatory Agents Atherosclerosis Anti-Infective Agents Antiprotozoal Agents Physiological Effects of Drugs Prediabetic State Overweight Arteriosclerosis Body Weight Antimalarials Signs and Symptoms Hyperinsulinism Antiparasitic Agents Pathologic Processes Sensory System Agents |
Therapeutic Uses Syndrome Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics Amebicides Dyslipidemias Antinematodal Agents Arterial Occlusive Diseases Disease Metabolic Syndrome X Metabolic Diseases Filaricides Vascular Diseases Diabetes Mellitus |