Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 8:01 AM
Study NCT ID:
NCT01702012
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2012-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Almased Multi-Center Diabetes Intervention Trial
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Evaluation of Almased on Glycemic Control and Metabolic Effects in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2020-01
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:
AMDIT
Brief Summary:
A 12 month multi-center randomization controlled study. Participants will be randomized to either a lifestyle education program or a meal replacement regimen with Almased, after an initial examination of eligibility criteria.
Primary outcome-HbA1c
Primary outcome-HbA1c
Detailed Description:
Age 21 + Male/Female gender Type 2 Diabetes Non-insulin dependent BMI 25-40 kg/m HbA1c 7.5-10%
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?: