Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT04547790
Study type Interventional
Source Mayo Clinic
Contact Renee M Weatherly
Phone 507-266-4680
Status Recruiting
Phase N/A
Start date December 23, 2020
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03239366 - A Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population Phase 2
Completed NCT04597229 - Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus N/A
Completed NCT03623139 - Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes N/A
Active, not recruiting NCT04599920 - Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life) N/A
Active, not recruiting NCT03422471 - Hypoglycemia and Autonomic Nervous System Function- B2 N/A
Active, not recruiting NCT04382521 - A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions N/A
Recruiting NCT04564391 - Whey or Casein - Liver Fat Reduction and Metabolic Improvement by Fast vs. Slow Proteins N/A
Recruiting NCT03458715 - The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin Phase 4
Terminated NCT03278236 - Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men? N/A
Completed NCT02974504 - Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN) Phase 4
Completed NCT05053828 - Type 2 Diabetes With Antiplatelet Drugs
Not yet recruiting NCT03659383 - The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine Phase 4
Completed NCT03542240 - Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome N/A
Completed NCT03657537 - Effects of Ketone Bodies on Cognition in Type 2 Diabetes Phase 1
Completed NCT03979768 - Risk Assessment of Type 2 Diabetes in Pharmacies N/A
Completed NCT03614039 - Effect of Probiotic and Smectite Gel on NAFLD N/A
Active, not recruiting NCT04994288 - A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients Phase 2/Phase 3
Completed NCT03290768 - Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3) N/A
Recruiting NCT04088851 - "The Role of the Liver for Interorgan Metabolic Crosstalk in Type 2 Diabetes" N/A
Completed NCT03643783 - Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients