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

  • STATUS
    Recruiting
  • End date
    Jan 19, 2022
  • participants needed
    120
  • sponsor
    Mayo Clinic
Updated on 19 February 2021

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.

Details
Condition Type2 Diabetes
Treatment Psyllium, Wheat Dextrin
Clinical Study IdentifierNCT04547790
SponsorMayo Clinic
Last Modified on19 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >18
May be on oral therapy (including metformin) or insulin
Most recent HgbA1c level measuring between 6.5 -10 within the last 3 months
May be on stable (> 4 weeks) statin dose or no statin therapy
Willing to sign informed consent and stay on current medical regimen
Does not use regular dietary fiber supplements; has not had any psyllium containing products in the previous 30 days; is willing to refrain from taking any other fiber containing supplement products during the study
Has not used systemic steroid agents in the last 30 days
Able to participate fully in all aspects of the study
Have access and ability to utilize text messaging or email

Exclusion Criteria

Unwilling/unable to participate
Comorbid inflammatory bowel disease, celiac sprue, nephrotic syndrome, severe cholestasis (e.g., primary biliary cirrhosis), or history of bariatric surgery/bowel resection
Alcohol use in excess of 14 drinks/week
Allergic reactions to psyllium or wheat dextrin
Has participated in a clinical drug study or used an investigational new drug during the previous 30 days
Self-Report of known or suspected pregnancy or immediate plans (within 3 months) of becoming pregnant
Currently breastfeeding
Has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
Anticipated or recent major changes in diet or exercise routine
Anticipated colonoscopy prep during 3 months of study period
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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