A Study to Evaluate the Effect of Improving Glycemic Control on Gastric Emptying in Type 1 and Type 2 Diabetes Mellitus

Overview

About this study

The purpose of this study is to evaluate the effects of improving glycemic control, and/or reducing glycemic variability on gastric emptying, intestinal barrier function, autonomic nerve functions, and epigenetic changes in subjects with type 1 diabetes mellitus (T1DM) and  type 2 diabetes mellitus (T2DM) who are switched to intensive insulin therapy as part of clinical practice.

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:

  • T1DM or T2DM of duration ≥ 5 years.
  • HbA1C > 7.5 %.
  • Able to provide written informed consent before participating in the study.
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria:

  • Severe nausea or vomiting precluding study assessments.
  • Use of medications that alter GI motility; e.g., narcotics or medications with significant anticholinergic effects. Subjects using metoclopramide or erythromycin will be enrolled provided it is safe to hold these medications for 48 hours before study procedures.
  • Patients likely to be treated with medications that directly affect gastrointestinal motility; e.g., pramlintide or GLP-1.
  • Patients likely to undergo major procedures; e.g., pancreas transplantation, dialysis or kidney transplantation within the next 3 months.
  • No nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin should be taken in the week before this test; this is an agent of exclusion only if medically safe to do so.
  • Patients who are allergic to eggs, wheat or milk or unwilling to consume these products.
  • For female patients who will participate in the validation arm of the study, pregnancy or breast feeding.

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

Adil Bharucha, M.B.B.S., M.D.

Open for enrollment

Contact information:

Amber Galbreath

(507)538-3883

Galbreath.Amber@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available