Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT01876992
Status:
TERMINATED
Last Update Posted:
2017-09-26
First Post:
2013-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metformin at the Cellular Level and Dosing for Diabetes Mellitus (DM)
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Pilot Study of Metformin-induced CBP Phosphorylation at the Cellular Level and Corresponding Clinical Dose Response in Adults and Children
Status:
TERMINATED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
All investigators/co-investigators relocating to other institutions.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators know that metformin works at the level of the cells in the body by acting on a protein called Cyclic amine monophosphate- Response Binding Elements (CREB) binding protein or Constitutive Reverter of eIF2α Phosphorylation (CREP) Binding Protein (CBP). What the investigators do not know is how this process is affected when the dose of the metformin is increased or changed.
Currently the same doses of metformin are often used in both children and adults, but it is possible that the dose of metformin should be based on age and weight. Understanding how CBP works could potentially help us to tailor metformin treatment individually for patients based on their age, weight and CBP response.
Currently the same doses of metformin are often used in both children and adults, but it is possible that the dose of metformin should be based on age and weight. Understanding how CBP works could potentially help us to tailor metformin treatment individually for patients based on their age, weight and CBP response.
Detailed Description:
Our studies have shown that metformin acts at the cellular level by acting on a target protein, Cyclic amine monophosphate-Response Binding Elements (CREB) binding protein or CREP Binding Protein (CBP). Patients are treated with many different doses of metformin, some patients respond well to low doses while others require much higher doses. The investigators do not understand why this may be and are interested in knowing if the investigators can treat patents effectively with low doses. What the investigators do not know is how this process is affected when the dose of the metformin is increased or changed. Changes in metformin's target protein will provide evidence on the effectiveness of the dose.
Also, currently the same doses of metformin are often used in both children and adults, but it is possible that the dose of metformin should be based on age and weight. Understanding how CBP works could potentially help us to tailor metformin treatment individually for patients based on their age, weight and CBP response.
Also, currently the same doses of metformin are often used in both children and adults, but it is possible that the dose of metformin should be based on age and weight. Understanding how CBP works could potentially help us to tailor metformin treatment individually for patients based on their age, weight and CBP response.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NA_00046072 | OTHER | JohnHopkinsU | View |