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Psyllium vs. Wheat Dextrin for Type 2 Diabetes
N/A
Waitlist Available
Led By Stephen Kopecky, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
May be on stable (> 4 weeks) statin dose or no statin therapy
Has not used systemic steroid agents in the last 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will compare the effects of Psyllium and Wheat Dextrin on lowering blood sugar and hemoglobin A1c, as well as any changes in laboratory values.
Eligible Conditions
- Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been taking a stable dose of statin medication for at least 4 weeks, or you are not taking statin medication at all.
Select...
You have not taken strong medicines called steroids in the last 30 days.
Select...
You are over 18 years old.
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You are allowed to take medications by mouth or insulin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HbA1c
Change in fasting blood sugar
Secondary outcome measures
Change in LDL-C
Change in blood pressure
Change in ceramides
+1 moreSide effects data
From 2017 Phase 2 trial • 54 Patients • NCT0319876783%
Diarrhea
25%
Constipation
4%
Decreased appetite
4%
Abdominal discomfort
4%
Abdominal pain
4%
Abdominal pain lower
4%
Flatulence
4%
Nausea
4%
Back pain
4%
Abdominal distension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: LIK066 + 50% CHO
Part A: LIK066 + 25% CHO
Part A: LIK066 + 0% CHO
Part A: LIK066 + 8% CHO
Part B: LIK066 + 50% CHO + NS
Part B: LIK066 + 50% CHO + PS
Part B: LIK066 + 50% CHO CC
Trial Design
2Treatment groups
Experimental Treatment
Group I: Wheat Dextrin groupExperimental Treatment1 Intervention
Subjects will take wheat dextrin once daily for the first three days, then twice daily starting Day 4 until the end of the study.
Group II: Psyllium groupExperimental Treatment1 Intervention
Subjects will take psyllium once daily for the first three days, then twice daily starting Day 4 until the end of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psyllium
2015
Completed Phase 4
~610
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,931 Total Patients Enrolled
Stephen Kopecky, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You recently made big changes in your diet or exercise routine, or plan to do so soon.You are planning to have a colonoscopy prep during the 3 months of the study.You have certain digestive or liver conditions, or a history of specific types of stomach or bowel surgeries.Your most recent HgbA1c level should be between 6.5 and 10 in the last 3 months.You have been taking a stable dose of statin medication for at least 4 weeks, or you are not taking statin medication at all.You have not taken strong medicines called steroids in the last 30 days.You drink more than 14 drinks per week.You are allergic to psyllium or wheat dextrin.You are over 18 years old.You are allowed to take medications by mouth or insulin.
Research Study Groups:
This trial has the following groups:- Group 1: Psyllium group
- Group 2: Wheat Dextrin group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are contributing to this investigation?
"Affirmative, the clinicaltrial.gov listing indicates that this medical experiment is still open for enrollment. It was initially posted on December 23rd 2020 and revised most recently February 2nd 2022. The study requires 120 volunteers across a single centre."
Answered by AI
Is this project actively searching for participants?
"According to clinicaltrials.gov, this trial has been receiving applicants since December 23rd 2020 and is still open for recruitment as of February 2nd 2022."
Answered by AI
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