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

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients identified as Type 2 diabetics will be identified via Mayo's electronic data system and verified by review of their medical record. Study coordinators will then send invitation letters to patients who meet initial inclusion criteria via mail or through the Mayo Patient Online Services (i.e. patient portal). Recruitment tools used will be flyer, an internet web posting, and a Mayo classified research ad placed in the Mayo classifieds. If patients are interested in participating, they will call or email the study coordinators to set up their baseline visit. Non-responders will be called up to 3 times if no answer. The study coordinator will ask if they received the letter and if they have any questions and if they are interested in participating. Potential subjects will be screened and consented either digitally or via paper. After consent, the study coordinator will complete the subject's medical history, review concomitant medications, and record vital signs during the baseline visit. Subjects will be randomized and instructed to complete a baseline blood draw, after which they will be given a 3-month supply of study product, a dosing scoop for the product and instructions on taking the assigned study product. They will be assigned to take the study product once daily for the first three days, then twice daily starting Day 4 until the end of the study. Subjects will be asked to respond to a text message or email message, daily, asking how many doses of study medication they took for that day (0, 1 or 2). The study coordinator will also contact subjects by phone or email to review and reinforce adherence to the protocol if the survey research center identifies subjects who have not responded to text messages within 3 days. Subjects will meet with study coordinators in person at 4, 8, and 12 weeks or study end to collect vitals, perform a symptom check, review concomitant medications, complete blood draws, and reinforce adherence to protocol.

Official Title
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Fiber and Diabetes (FAD) Study: Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markers in DM2

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Psyllium
* Dietary Supplement: Wheat Dextrin


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psyllium group<br>Subjects will take psyllium once daily for the first three days, then twice daily starting Day 4 until the end of the study. | Dietary Supplement: Psyllium<br>* One level scoop (12.5mL) of 5.1g of psyllium fiber twice a day with 8 ounces water<br>* Other names: Metamucil;|
| Experimental: Wheat Dextrin group<br>Subjects will take wheat dextrin once daily for the first three days, then twice daily starting Day 4 until the end of the study. | Dietary Supplement: Wheat Dextrin<br>* One level scoop (12.5 mL) of 1.7g wheat dextrin fiber twice a day with 8 ounces water<br>* Other names: Benefiber;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting blood sugar | The two endpoints of primary interest for this study are HbA1c and fasting glucose. The primary analysis will assess the change in these endpoints between the two treatment groups over the 12 week study period. To estimate the difference between study groups a linear mixed model will be used to account for repeated measures of subjects. The independent variable will be Psyllium group and the baseline outcome result will be included as a covariate. | 12 weeks | 
| Change in HbA1c | The primary analysis will assess the change in these endpoints between the two treatment groups over the 12 week study period. To estimate the difference between study groups a linear mixed model will be used to account for repeated measures of subjects. The independent variable will be Psyllium group and the baseline outcome result will be included as a covariate. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-C | As a secondary analysis, LDL-C, will be collected and analyzed. to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate. | 12 weeks | 
| Change in ceramides | As a secondary analysis, ceramides will be collected and analyzed to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate. | 12 weeks | 
| Change in blood pressure | Blood pressure will be collected and analyzed. For vital signs measurements a paired t-test will be used to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate. | 12 weeks | 
| Change in weight | Weight will be collected and analyzed. For vital signs measurements a paired t-test will be used to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate. | 12 weeks |