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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 below
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You have been taking a stable dose of statin medication for at least 4 weeks, or you are not taking statin medication at all.
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You have not taken strong medicines called steroids in the last 30 days.
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You are over 18 years old.
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You are allowed to take medications by mouth or insulin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

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 more

Side effects data

From 2017 Phase 2 trial • 54 Patients • NCT03198767
83%
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

Psyllium Clinical Trial Eligibility Overview. Trial Name: NCT04547790 — N/A
Type 2 Diabetes Research Study Groups: Psyllium group, Wheat Dextrin group
Type 2 Diabetes Clinical Trial 2023: Psyllium Highlights & Side Effects. Trial Name: NCT04547790 — N/A
Psyllium 2023 Treatment Timeline for Medical Study. Trial Name: NCT04547790 — N/A

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
~28 spots leftby Mar 2025