Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT06333132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat)
Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Organization:
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dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn.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:
False
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?: