Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 14-002098
NCT ID: NCT02170870
Sponsor Protocol Number: 14-002098
About this study
To understand why patients with indigestion with or without diabetes have gastrointestinal symptoms and in particular to understand where the symptoms are related to increased sensitivity to nutrients.
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. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
Inclusion criteria for controls
- Healthy male or non-pregnant, non-breastfeeding female volunteers;
- 18-70 years old;
- 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
Additional inclusion criteria for patients
- Symptoms of dyspepsia (i.e., early satiety, postprandial discomfort, nausea, vomiting, regurgitation)
- Patients in the DM group will also require Type 1 or 2 DM of ≥ 3 years duration; in patients with type 2 DM, the dyspepsia symptoms should have begun or worsened after DM was diagnosed
- Total serum lipase ≥ 10 IU/ml
Exclusion criteria - for patients and controls
- Major abdominal surgery (i.e., appendectomy, cholecystectomy, tubal ligation, hysterectomy, and limited colonic resection are permissible)
- Clinical evidence (including physical exam and EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
- Opiates, alpha adrenergic agonists, metoclopramide, and high doses of anticholinergic agents (eg, amitriptyline greater than 50 mg daily). If medically safe, these drugs may be discontinued for four half lives prior to study assessments
- Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain
- Use of tobacco products within the past six months or NSAIDs or aspirin within the past week (since they all may affect intestinal permeability)
- Bleeding or clotting disorders or medications that increase risk of bleeding from mucosal biopsies
- Positive tissue transglutaminase antibodies (TTG), serum lipase < 10IU/L
- For two days prior to studies, subjects will be instructed to avoid ingestion of artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), foods containing lactulose or mannitol
- Pregnant or breast-feeding females
- Known intolerance or allergy to eggs
- Poor peripheral venous access, if central venous access is not available
- Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study
Exclusion criteria for controls only
- Current symptoms of a functional gastrointestinal disorder assessed by questionnaire
Exclusion criteria for patients only
- Severe vomiting that would preclude tube placement or participation in the study
- Structural cause for symptoms by endoscopy within the past 48 months
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.