Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004769
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2000-02-24
Brief Title:
Study of Muscle Wasting and Altered Metabolism in Patients With Myotonic Dystrophy
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Myotonic DystrophyMuscle Wasting and Altered Metabolism
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| URMC-445 | OTHER | University of Rochester | None |
| URMC-583 | OTHER | None | None |