- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04547790
A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2
Fiber and Diabetes (FAD) Study: Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markers in DM2
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psyllium group
Subjects will take psyllium once daily for the first three days, then twice daily starting Day 4 until the end of the study.
|
One level scoop (12.5mL) of 5.1g of psyllium fiber twice a day with 8 ounces water
Other Names:
|
Experimental: Wheat Dextrin group
Subjects will take wheat dextrin once daily for the first three days, then twice daily starting Day 4 until the end of the study.
|
One level scoop (12.5 mL) of 1.7g wheat dextrin fiber twice a day with 8 ounces water
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fasting blood sugar
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen Kopecky, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-010612
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type2 Diabetes
-
Mathias Ried-LarsenUnknownDiabetes Mellitus, Type 2 | Type 2 Diabetes Mellitus | Type2 Diabetes | Type2 Diabetes MellitusDenmark
-
Johns Hopkins UniversityBeth Israel Deaconess Medical CenterActive, not recruitingHypertension | Diabetes Mellitus, Type 2 | Diabetes | Diabetes type2 | Type 2 Diabetes | Type2 Diabetes | Type II Diabetes | High Blood PressureUnited States
-
Sigrid Therapeutics ABCompletedOverweight | PreDiabetes | Prediabetic State | Type2 Diabetes | Obese | Type2 Diabetes Mellitus | Pre DiabetesFinland, Sweden
-
University of ChicagoCompleted
-
Michigan State UniversityUniversity of Michigan; Claremont Graduate UniversityUnknown
-
University of AlbertaSherwood Park Strathcona County Primary Care Network, AlbertaCompleted
-
Brittany L SmallsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Dong-A ST Co., Ltd.CompletedType2 DiabetesKorea, Republic of
-
LMC Diabetes & Endocrinology Ltd.Merck Sharp & Dohme LLC; Syreon CorporationWithdrawnType2 Diabetes
Clinical Trials on Psyllium
-
Unity Health TorontoUnknownHypercholesterolemia | Cardiovascular Risk Factor
-
University of UtahCompletedKidney DiseaseUnited States
-
Procter and GambleCompleted
-
Hungkuang UniversityNot yet recruitingSchizophrenia | Constipation | PsylliumTaiwan
-
Nutrabiotix, LLCRush University Medical CenterTerminatedConstipation-predominant IBS (IBS-C)United States
-
Francesco GabrielliCompletedConstipation | IncontinenceItaly
-
Procter and GambleDuke UniversityCompletedImpaired Fasting GlucoseUnited States
-
University of NottinghamIronwood Pharmaceuticals, Inc.Completed
-
Procter and GambleCompleted
-
US Department of Veterans AffairsCompletedFecal IncontinenceUnited States