Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222521
Status:
COMPLETED
Last Update Posted:
2005-09-22
First Post:
2005-09-14
Brief Title:
Insulin Glargine Vs Standard Insulin Therapy
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Comparison of Insulin Glargine Vs Standard Insulin Therapy in CFRD Without Fasting Hyperglycemia
Status:
COMPLETED
Status Verified Date:
2005-09
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:
This Study is designed to determine whether treatment of CFRD with glargine insulin will improve hemoglobin A1c weight and muscle mass compared to the traditional regimen of bedtime NPH insulin
Detailed Description:
The majority of cystic fibrosis CF patients now survive beyond childhood and CF related diabetes CFRD due to insulin deficiency is common CFRD with fasting hyperglycemia occurs in about 15 of adult CF patients Standard insulin therapy has relied primarily on meal coverage with rapid-acting insulin Usually basal insulin coverage is only provided overnight with modest doses of NPH insulin The practice of providing minimal basal insulin in CFRD is based on the fact that most of these patients unless they are acutely ill are able to maintain relatively normal blood glucose levels during the day without it In addition anecdotal experience has suggested that daytime NPH insulin or once to twice daily ultralente insulin frequently lead to hypoglycemia in the CFRD patient This practice which is based on practical clinical considerations ignores the established relationship between insulin deficiency and clinical deterioration in CFRD BMI and pulmonary function deteriorate much more rapidly in CF patients with diabetes than in CF patients with normal glucose tolerance Insulin deficiency leads to increased protein catabolism and fatty acid turnover The resulting loss of weight and lean body mass contributes to pulmonary disease and clinical decline
We hypothesize that
1 Basal insulin coverage with insulin glargine will improve hemoglobin A1c weight and muscle mass in patients with CFRD with fasting hyperglycemia compared to traditional regimens with less basal insulin
2 Because of the peakless action of insulin glargine this will be accomplished without serious hypoglycemia
We hypothesize that
1 Basal insulin coverage with insulin glargine will improve hemoglobin A1c weight and muscle mass in patients with CFRD with fasting hyperglycemia compared to traditional regimens with less basal insulin
2 Because of the peakless action of insulin glargine this will be accomplished without serious hypoglycemia
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