A Study of the Effect of Colesevelam on Glucose Metabolism in Patients with Type 2 Diabetes

Overview

About this study

The purpose of this study is to determine the metabolic effects of Colesevelam, particularly for the ability to lower blood sugar after a meal in type 2 diabetics, in order to develop a better understanding of it's potential role in the treatment of obesity.

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 35-70 years
  • Body Mass Index greater than 19kg/m^2 or less than 40kg/m^2 
  • Total weight less than 130 kilograms
  • Negative pregnancy test for women of childbearing potential
  • Absence of gastrointestinal symptoms
  • Signed informed consent
  • Type 2 Diabetics, Treated with diet and/or metformin
    • Must be on stable therapeutic doses of metformin and/or lipid-lowering agents for more than 3 months

Exclusion Criteria

  • Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders
    • A screening Bowel Disease Questionnaire will be used to exclude irritable bowel syndrome
    • History of dysphagia or intestinal motility disorders will be exclude
  • Prior history of pancreatitis
  • Prior history of hypertriglyceridemia (500mg/dL or greater)
  • Currently using a bile-acid binding resin such as colesevelam, colestipol, colestimide or cholestyramine
  • Insulin-treated type 2 diabetes mellitus, 
  • Have received an inhibitors of dipeptidyl peptidase 4 (DPP-4 inhibitors), "gliptins" (a class of oral hypoglycemics), Byetta or a sulfonylurea agent in the past three months
  • HbA1c greater than 9.0%
  • Have not been stable on all medications for a period exceeding 3 months
  • Use of drugs or agents within the past 2 weeks or planned use in the subsequent 4 weeks during the study period that:
    • Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRIs) and newer antidepressants.
    • Opiate-based analgesic drugs 
      • Intermittent or chronic use of aspirin or non-steroidal anti-inflammatory drugs (NSAID) will be allowed
    • Antihistamines
    • Anticholinergic agents
  • Female subjects who are pregnant or breast-feeding
    • Females must be either surgically sterilized, postmenopausal (>12 months since last menses), or, if of childbearing potential, using reliable methods of contraception as determined by the physician
  • Clinical evidence (including physical exam and Electrocardiogram) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interferes with the objectives of the study
    • Any candidate participants with such disorders mentioned will be referred to their general physician

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

Adrian Vella, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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