Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus

Overview

About this study

To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.

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:

  1. Obese subjects with BMI > 30 kg/m2 with type 2 diabetes mellitus taking DPP4 inhibitors alone or in combination with metformin.
  2. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope.
  3. Willing to provide consent

Exclusion Criteria:

  1. Structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
  2. Irritable bowel syndrome
  3. Bristol stool type classification 4-7 per Bowel Disease questionnaire.
  4. Subjects with other treatment for type 2 diabetes mellitus.
  5. Subjects with HbA1c > 8%
  6. Females who are pregnant or breastfeeding
  7. Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or lorcaserin.
  8. Subjects who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than type 2 diabetes mellitus), and unstable psychiatric disease.
  9. Subjects who have donated blood or plasma in the past 8 weeks.
  10. Subjects who have participated in another study within the past 30 days.

 

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

Rochester, Minn.

Mayo Clinic principal investigator

Andres Acosta, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20204587

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