Molecular determinants of glucose sensing in human gastrointestinal tract of patients with type 2 diabetes and healthy volunteers.

Phase 4

• Conditions: Type II Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12613000843752
• Lead Sponsor: Dr. Nam Q Nguyen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients with type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone or metformin, with a HbA1c =/< 7.5%.
Healthy volunteers, matched as closely as possible to the diabetic subjects for age, sex, and body mass index.

Exclusion Criteria

Significant illness other than diabetes, including impairment to cardiovascular or respiratory function that limits a subject’s activity and therefore would represent a risk to undertaking endoscopy safely (American Society of Anesthesiologists Grade 3 or more)
History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms (as assessed by a validated upper gastrointestinal symptom questionnaire, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
Haemoglobin below the lower limit of the normal range (ie. <135g/L for men and 115g/L for women), and ferritin below the lower limit of normal (ie. <10mcg/L)
Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests (> 2 times upper limit of normal))
History of severe respiratory, cardiovascular, hepatic and/or renal disease, chronic alcohol abuse or epilepsy (excluded by history)
Subjects requiring medication that may influence gastrointestinal function
Any patient with coagulopathy.
Allergy to glibencamide and/or sulphonamide derivatives
Patients with Thrombocytopenia
Patients requiring treatment with anticoagulants, anti-platelet agents and NSAIDS
Presence of mucosal abnormalities at sigmoidoscopy such as inflammatory bowel disease and colorectal cancer.
Body mass index greater than 32 kg/m2
Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes per day
Female patients not using appropriate contraceptive method (ie oral contraceptive pill, diaphragm, Depo-Provera hormonal contraceptive injection, intrauterine device (IUD), Norplant method)
Vegetarian, lactation, or pregnancy (verified by urine testing in women of reproductive age; in these subjects, the study will be completed during the follicular phase of the menstrual cycle)
Donation of blood within the previous 3 months
Participation in any other research studies within the previous 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified