Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04547790
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2020-09-08
Brief Title:
A Study to Assess the Effect of Psyllium vs Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Fiber and Diabetes FAD Study Effect of Psyllium vs Wheat Dextrin on Glycemic Control and Inflammatory Markers in DM2
Status:
COMPLETED
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:
None
Brief Summary:
The purpose of this study is to determine which of Psyllium and Wheat Dextrin is more effective in lowering fasting blood sugar and hemoglobin A1c and to evaluate the effects they have on laboratory values
Detailed Description:
Patients identified as Type 2 diabetics will be identified via Mayos electronic data system and verified by review of their medical record Study coordinators will then send invitation letters to patients who meet initial inclusion criteria via mail or through the Mayo Patient Online Services ie patient portal Recruitment tools used will be flyer an internet web posting and a Mayo classified research ad placed in the Mayo classifieds If patients are interested in participating they will call or email the study coordinators to set up their baseline visit Non-responders will be called up to 3 times if no answer The study coordinator will ask if they received the letter and if they have any questions and if they are interested in participating
Potential subjects will be screened and consented either digitally or via paper After consent the study coordinator will complete the subjects medical history review concomitant medications and record vital signs during the baseline visit Subjects will be randomized and instructed to complete a baseline blood draw after which they will be given a 3-month supply of study product a dosing scoop for the product and instructions on taking the assigned study product They will be assigned to take the study product once daily for the first three days then twice daily starting Day 4 until the end of the study
Subjects will be asked to respond to a text message or email message daily asking how many doses of study medication they took for that day 0 1 or 2 The study coordinator will also contact subjects by phone or email to review and reinforce adherence to the protocol if the survey research center identifies subjects who have not responded to text messages within 3 days
Subjects will meet with study coordinators in person at 4 8 and 12 weeks or study end to collect vitals perform a symptom check review concomitant medications complete blood draws and reinforce adherence to protocol
Potential subjects will be screened and consented either digitally or via paper After consent the study coordinator will complete the subjects medical history review concomitant medications and record vital signs during the baseline visit Subjects will be randomized and instructed to complete a baseline blood draw after which they will be given a 3-month supply of study product a dosing scoop for the product and instructions on taking the assigned study product They will be assigned to take the study product once daily for the first three days then twice daily starting Day 4 until the end of the study
Subjects will be asked to respond to a text message or email message daily asking how many doses of study medication they took for that day 0 1 or 2 The study coordinator will also contact subjects by phone or email to review and reinforce adherence to the protocol if the survey research center identifies subjects who have not responded to text messages within 3 days
Subjects will meet with study coordinators in person at 4 8 and 12 weeks or study end to collect vitals perform a symptom check review concomitant medications complete blood draws and reinforce adherence to protocol
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