Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
Study NCT ID:
NCT05791968
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2023-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Donation Could Improve Insulin Sensitivity
Sponsor:
University of Castilla-La Mancha
Organization:
Study Overview
Official Title:
Effects of a Standard Blood Bank Donation on Insulin Sensitivity in Adults With Pre-diabetes and Abdominal Obesity
Status:
COMPLETED
Status Verified Date:
2023-03
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:
GLUCFER
Brief Summary:
Studies in the literature suggest that people with obesity have an excess of stored iron. There is possibly an inverse relationship between ferritin levels and the actions of insulin on glycemic control. The reduction of stored iron by simply donating blood could result in improvements in glycemic control in people with obesity and prediabetes. We propose, to reduce ferritin levels through a standard donation of a unit of whole blood, and to measure if it positively affects glycemic control.
Detailed Description:
Individuals with pre-diabetes and abdominal obesity will be randomized to either a donation group (DON) or a control group (CONT) in a double-blind fashion (RCT).
Insulin sensitivity during an oral glucose tolerance test (OGTT) and isotopically measured rate of appearance of endogenous and exogenous glucose will be measured on 2 occasions.
1. Two weeks prior to DON/CONT
2. Two weeks after to DON/CONT
Indexes of the bodily iron stores will be measured after DON/CONT to evaluate if the primary treatment was effective.
Insulin sensitivity during an oral glucose tolerance test (OGTT) and isotopically measured rate of appearance of endogenous and exogenous glucose will be measured on 2 occasions.
1. Two weeks prior to DON/CONT
2. Two weeks after to DON/CONT
Indexes of the bodily iron stores will be measured after DON/CONT to evaluate if the primary treatment was effective.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: