Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-13
Brief Title:
Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes DIABeat
Sponsor:
Azienda Ospedaliero Universitaria Pisana
Organization:
Azienda Ospedaliero Universitaria Pisana
Study Overview
Official Title:
Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
DiabEATit
Brief Summary:
The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission
Detailed Description:
Participants will undergo an intensive individualized dietary treatment to achieve a 10 reduction in body weight during which glucose-lowering therapy will be withdrawn Before and after the intervention the patients will undergo
measurement of fasting glucose and glycated hemoglobin
Indirect calorimetry
oral glucose tolerance test
intravenous glucose tolerance test
quality of life and diet-related questionnaires
72-hour food records
At the end of the protocol subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse
measurement of fasting glucose and glycated hemoglobin
Indirect calorimetry
oral glucose tolerance test
intravenous glucose tolerance test
quality of life and diet-related questionnaires
72-hour food records
At the end of the protocol subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse
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