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Study of Muscle Wasting and Altered Metabolism in Patients With Myotonic Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004769
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):
Richard T Moxley, University of Rochester

Tracking Information
First Submitted Date February 24, 2000
First Posted Date February 25, 2000
Last Update Posted Date January 28, 2013
Study Start Date December 1993
Actual Primary Completion Date March 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2013)
Quantitative myometry (QMT) [ Time Frame: Visit 1 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Muscle Wasting and Altered Metabolism in Patients With Myotonic Dystrophy
Official Title Myotonic Dystrophy:Muscle Wasting and Altered Metabolism
Brief Summary

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.

Detailed Description

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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population National sample
Condition Myotonic Muscular Dystrophy
Intervention Not Provided
Study Groups/Cohorts
  • Myotonic dystrophy
    Subjects with myotonic dystrophy
  • Healthy controls
    Healthy subjects
  • Disease controls 1
    Subjects with FSHD
  • Disease controls 2
    Subjects with CMT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 23, 2005)
130
Original Enrollment Same as current
Actual Study Completion Date March 2000
Actual Primary Completion Date March 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinically mild or moderate myotonic dystrophy (DM), proximal myotonic myopathy (PROMM), facioscapulohumeral muscular dystrophy (FSH) or, Charcot-Marie-Tooth (CMT)
  • Mild or moderate DM defined as: Mild muscle weakness in the limbs, modest facial weakness, and mild grip myotonia; Moderate muscle weakness in the limbs, typical DM facies, and prominent grip myotonia

Exclusion Criteria:

  • Prior or concurrent therapy
  • Obese
  • Concurrent acute illness
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00004769
Other Study ID Numbers 199/11770
URMC-583 ( Other Identifier: University of Rochester )
URMC-445 ( Other Identifier: University of Rochester )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Richard T Moxley, University of Rochester
Study Sponsor University of Rochester
Collaborators Not Provided
Investigators
Study Chair: Richard T. Moxley, III University of Rochester
PRS Account University of Rochester
Verification Date January 2013