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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Rochester |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004769 |
OBJECTIVES: I. Examine the interrelationships between muscle wasting (phenotype), the degree of myotonic dystrophy (DM) gene expression (genotype) in patients with DM. II. Characterize the insulin resistance in these patients. III. Assess the glucose uptake in the leg and forearm tissues of these patients.
IV. Determine the stability of the DM gene lesion in muscles over a 5-10 year period.
Condition | Intervention |
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Muscular Dystrophy |
Drug: dextrose Drug: insulin |
Study Type: | Observational |
Study Design: | Screening |
Estimated Enrollment: | 130 |
Study Start Date: | December 1993 |
PROTOCOL OUTLINE: Patients are placed on a meatless diet 3 days prior to study entry.
During the first 5-day hospital stay, patients receive an oral glucose tolerance test, an intravenous glucose tolerance test, and an intravenous infusion of insulin and glucose (dextrose) to determine the degree of insulin resistance. Patients also receive dual x-ray absorptiometry (DEXA) scan and total body potassium count to measure muscle mass. Patients undergo strength testing and physical fitness screening. A needle biopsy is performed to investigate the genetic alterations associated with this disease. During the second 3-day hospital stay, patients receive an intravenous infusion of insulin, stable isotopic glucose, and stable isotopic glycerol. During the third 3-day hospital stay, a catheter is placed in the femoral artery, femoral vein, and in each arm. Patients receive an infusion of stable isotopic glucose, stable isotopic phenylalanine, and insulin. Measurements of the balance of amino acids and glucose across the forearm and leg are completed. Green dye is infused to measure blood flow in the leg.
Ages Eligible for Study: | 21 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | 199/11770, URMC-583, URMC-445 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004769 History of Changes |
Health Authority: | United States: Federal Government |
genetic diseases and dysmorphic syndromes muscular dystrophy neurologic and psychiatric disorders rare disease |
Rare Diseases Insulin Muscular Dystrophies Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Neuromuscular Diseases Genetic Diseases, Inborn |
Mental Disorders Myotonic Dystrophy Atrophy Myotonic Dystrophy 1 Muscular Atrophy Myotonia Atrophica Muscular Dystrophy |
Muscular Dystrophies Muscular Diseases Genetic Diseases, Inborn Neuromuscular Diseases |
Musculoskeletal Diseases Muscular Disorders, Atrophic Nervous System Diseases |