Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05791968
Status:
RECRUITING
Last Update Posted:
2023-04-03
First Post:
2023-03-17
Brief Title:
Blood Donation Could Improve Insulin Sensitivity
Sponsor:
University of Castilla-La Mancha
Organization:
University of Castilla-La Mancha
Study Overview
Official Title:
Effects of a Standard Blood Bank Donation on Insulin Sensitivity in Adults With Pre-diabetes and Abdominal Obesity
Status:
RECRUITING
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 DONCONT
2 Two weeks after to DONCONT
Indexes of the bodily iron stores will be measured after DONCONT 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 DONCONT
2 Two weeks after to DONCONT
Indexes of the bodily iron stores will be measured after DONCONT to evaluate if the primary treatment was effective
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None