Composition & Function of Sarcoplasmic Reticulum in Persons With the Metabolic Syndrome
NCT ID: NCT02122666
Last Updated: 2024-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
27 participants
OBSERVATIONAL
2014-03-31
2024-02-15
Brief Summary
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Detailed Description
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Based on the muscle biopsies of four healthy persons, it was found that human muscle contains similar phospholipids and phospholipid ratios to mice. It is hypothesized that these phospholipid signatures may be predictive of the metabolic status of humans as well. The specific aims of this study are to determine if the composition and function of the sarcoplasmic reticulum is altered in persons with the metabolic syndrome compared to lean controls. This knowledge could provide new understanding of impediments to effective therapy, novel biomarkers of disease progression, and innovative treatment targets for diabetes.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Metabolic Syndrome
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy
A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
Control
Muscle biopsy to determine sarcoplasmic reticulum composition and function, Oral Glucose tolerance test with insulin levels at time points to determine Insulin sensitivity, DEXA scan to determine lean muscle and fat mass
muscle biopsy
A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
Interventions
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muscle biopsy
A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
Eligibility Criteria
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Inclusion Criteria
Exclusion:
Currently on any significant prescription medications other than oral contraceptives in women Currently Pregnant Current Tobacco Use
Subjects with the Metabolic Syndrome
Inclusion:
Sedentary: No routine exercise, walking \<10,000 steps per day Age \>18 and \<65 Body Mass Index (BMI) \>30
Meet at least three of the following Adult Treatment Panel (ATP) III criteria for the metabolic syndrome:
waist circumference \> or = 40 inches in men, \> or = 35 inches in women blood triglycerides \> or = 150 mg/dL blood HDL cholesterol \<40 mg/dL in men, \<50 in women blood pressure \> or = 130 mmHg systolic, or \> or = 85 mmHg diastolic fasting blood sugar \> or = 100 mg/dL
Exclusion:
Diagnosed with Type 2 diabetes, coronary artery disease, cancer, liver, lung, or kidney disease or any other major illness
Currently on any significant prescription medications other than:
oral contraceptives in women More than two standard medication for stage 1 hypertension in men or women (blood pressure 140-159/90-99) Currently Pregnant Current Tobacco Use
18 Years
65 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Clay F. Semenkovich, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Janet B McGill, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Washington U in St. Louis, Endocrinology Current Clinical Studies
Clay F. Semenkovich, MD
Washington U in St. Louis; Research Participant Registry
Other Identifiers
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HRPO201311099
Identifier Type: -
Identifier Source: org_study_id
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