Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-04 @ 8:38 PM
Study NCT ID:
NCT03469492
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2018-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study
Status:
COMPLETED
Status Verified Date:
2024-02
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:
To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.
Detailed Description:
Polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and higher intracellular glutathione levels. Furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K23DK109284-01 | NIH | None | https://reporter.nih.gov/quic… | View |