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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

Be older than 18 years old

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Decreased appetite

Abdominal discomfort

Abdominal pain

Abdominal pain lower

Flatulence

Nausea

Back pain

Abdominal distension

100%

80%

60%

40%

20%

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

~720

Wheat Dextrin

2020

N/A

~110

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Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,227 Previous Clinical Trials

3,771,567 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

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2

Stephen L. Kopecky 2020. "A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04547790.