Clinical trial NCT04547790: A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2
Official title: Fiber and Diabetes (FAD) Study: Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markers in DM2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in fasting blood sugar
timeFrame: 12 weeks
measure: Change in HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in LDL-C
timeFrame: 12 weeks
measure: Change in ceramides
timeFrame: 12 weeks
measure: Change in blood pressure
timeFrame: 12 weeks
measure: Change in weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephen Kopecky, MD
role: PRINCIPAL_INVESTIGATOR
References: