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

Overview

About this study

The purpose of this study is to assess whether psyllium is more effective in lowering fasting blood sugar and HbA1c, and to evaluate the effect of psyllium compared to wheat dextrin on the following laboratory markers:  LDL-C, inflammatory markers such as ceramides and hsCRP, and branch chain amino acids which predict Diabetes Mellitus (DM).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Kopecky, M.D.

Open for enrollment

Contact information:

Heather Ondler Hinson M.S.

(507) 422-6823

OndlerHinson.Heather@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available