Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131755
Status:
COMPLETED
Last Update Posted:
2011-07-18
First Post:
2005-08-17
Brief Title:
Efficacy of Diazoxide in Type 1 Diabetes
Sponsor:
Grill Valdemar MD
Organization:
Grill Valdemar MD
Study Overview
Official Title:
Efficacy of 6 Months Treatment With Diazoxide at Bedtime in Preventing Beta-cell Demise in Newly Diagnosed Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2011-07
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:
The purpose of this study is to find out if Diazoxide can partly retain insulin production in newly diagnosed type 1 diabetes patients
Detailed Description:
At the time of diagnosis most subjects with type 1 diabetes retain significant endogenous insulin secretion as assessed by C-peptide measurements Although not sufficient for the needs of the individual residual insulin secretion is important for metabolic control for avoidance of hypoglycemic episodes and perhaps for protection against diabetic complications To retain residual endogenous insulin secretion in type 1 diabetes is thus highly desirable
Residual insulin secretion deteriorates during the course of type 1 diabetes The underlying autoimmune process is a major determinant of deterioration
However also measures that do not directly target the immune system could be beneficial The DCCT study randomised subjects with type 1 diabetes to either intensive or conventional insulin treatment The intensive insulin treatment markedly retarded deterioration in C-peptide levels during 5 years of observation The favourable effect could be due to lesser hyperglycemia per se Alternatively the effect of intensive insulin treatment could be secondary to lesser degree of over-stimulation of the patients beta-cells
It is by now established that relief from over-stimulation by diazoxide favourably affects beta-cell function and that such treatment can retard a decline in residual insulin secretion in subjects with newly diagnosed type 1 diabetes Diazoxide has been used in clinical practice for three decades without major safety concerns
Disturbing albeit reversible side effects are halting long-term studies with diazoxide in type 1 diabetes The researchers find that lower and intermittent ie night time dosing of diazoxide produces no measurable side effects in subjects with type 2 diabetes
This is a double blinded placebo controlled study with 35 participants with newly diagnosed type 1 diabetes are randomised into either placebo or Diazoxide for 6 months The patients will be followed up after intervention for at least 12 months
Beta cell function and glycemic control will be monitored
Residual insulin secretion deteriorates during the course of type 1 diabetes The underlying autoimmune process is a major determinant of deterioration
However also measures that do not directly target the immune system could be beneficial The DCCT study randomised subjects with type 1 diabetes to either intensive or conventional insulin treatment The intensive insulin treatment markedly retarded deterioration in C-peptide levels during 5 years of observation The favourable effect could be due to lesser hyperglycemia per se Alternatively the effect of intensive insulin treatment could be secondary to lesser degree of over-stimulation of the patients beta-cells
It is by now established that relief from over-stimulation by diazoxide favourably affects beta-cell function and that such treatment can retard a decline in residual insulin secretion in subjects with newly diagnosed type 1 diabetes Diazoxide has been used in clinical practice for three decades without major safety concerns
Disturbing albeit reversible side effects are halting long-term studies with diazoxide in type 1 diabetes The researchers find that lower and intermittent ie night time dosing of diazoxide produces no measurable side effects in subjects with type 2 diabetes
This is a double blinded placebo controlled study with 35 participants with newly diagnosed type 1 diabetes are randomised into either placebo or Diazoxide for 6 months The patients will be followed up after intervention for at least 12 months
Beta cell function and glycemic control will be monitored
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 |
|---|---|---|---|
| Eudract 2004-004103-38 | None | None | None |