Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00004769
Study type Observational
Source University of Rochester
Contact
Status Completed
Phase N/A
Start date December 1993
Completion date March 2000

See also
  Status Clinical Trial Phase
Recruiting NCT00082108 - Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Registry
Completed NCT05027269 - Study of AOC 1001 in Adult Myotonic Dystrophy Type 1 (DM1) Patients Phase 1/Phase 2
Recruiting NCT06411288 - Global Study of Del-desiran for the Treatment of DM1 Phase 3