A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory M… (NCT04547790) | Clinical Trial Compass
CompletedNot Applicable
A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2
United States101 participantsStarted 2020-12-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Subject population: This will include adult ECH patients (18 years of age or older) with DM2 who receive their care and diabetic management through Primary Care in Rochester at Mayo Clinic.
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 j…